← Trials/Trial dossier/NCT02322021
Dose-Finding Study To Evaluate Safety, Tolerability, and Efficacy of E2609 in Participants With Mild Cognitive Impairment Due to Alzheimer's Disease (Prodromal Alzheimer's Disease) and Mild to Moderate Dementia Due to Alzheimer's Disease
A Placebo-Controlled, Double-Blind, Parallel-Group, Randomized, Proof-of-Concept, Dose-Finding Study To Evaluate Safety, Tolerability, and Efficacy of E2609 in Subjects With Mild Cognitive Impairment Due to Alzheimer's Disease (Prodromal Alzheimer's Disease) and Mild to Moderate Dementia Due to Alzheimer's Disease
Lead sponsor
Asset
Elenbecestat
Listed sites
21
Recruiting sites
-
Enrollment
70
actual
Study population
Alzheimer’s disease, MCI / preclinical Alzheimer’s
Key I/E criteria
•MCI due to AD / prodromal AD•Amyloid biomarker required (PET)•Study partner/caregiver required•Background AD symptomatic therapy, if used: stable ≥12 weeks
Primary endpoints
•Core Phase•TEAEs and SAEs•Markedly Abnormal Vital Sign Values
Footprint
Where this trial recruits
Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Timeline
Milestones
Assets
Drug assets
Study populations
Who this study enrolls
Eligibility
Who can enroll
Inclusion criteria
Participants must meet all of the following criteria to be included in this study:
1. Meets the core clinical research criteria of the National Institute on Aging-Alzheimer's Association (NIA-AA) for MCI due to AD (which is consistent with Prodromal AD) or AD dementia and is 'staged' or classified as either MCI or mild to moderate dementia.
2. Amyloid positive Positron Emission Tomography (PET) image based on centralized PET scan reading.
3. Male or female, age 50 to 85 years, inclusive at time of consent.
4. Must have an identified caregiver or informant who is willing and able to provide follow-up information on the participant throughout the course of the study.
5. If receiving an Acetylcholinesterase Inhibitor (AChEI) or memantine, must have been on a stable dose for at least 12 weeks before the Baseline cognitive assessments, with no plans for dose adjustment in the foreseeable future. Treatment-naive participants can be entered into the study but there should be no plans to initiate treatment with AChEIs or memantine at the time of entry into the study.
6. Must have been on stable doses of all other permitted chronically used concomitant medications (that is, not related to their cognitive decline) for at least 4 weeks before randomization
Exclusion criteria
Participants who meet any of the following criteria will be excluded from this study:
1. Any neurological condition that may be contributing to cognitive impairment above and beyond that caused by the participant's AD pathology, including any co-morbidities such as cerebrovascular disease, detected by medical history, neurological examination, or magnetic resonance imaging (MRI).
2. History of transient ischemic attacks or stroke within 12 months of Screening.
3. History of epilepsy.
4. Evidence of depression on a rating scale at Screening or any psychiatric diagnosis or symptoms, (example, hallucinations, major depression, etc.) that could confound the diagnosis or could interfere with study assessments or procedures. This includes suicidal ideation or suicidal behavior within 6 months prior to Screening, or hospitalization or treatment for suicidal behavior in the past 5 years.
5. Abnormally low serum vitamin B12.
6. Thyroid stimulating hormone above the normal range. This applies to all participants regardless of whether or not they are taking thyroid supplements.
7. Participants with liver disease (hepatic impairment), at Screening or Baseline. Participant with Gilbert's syndrome need not be excluded.
8. Not able to have a MRI, PET scanning, or cerebrospinal fluid (CSF) collection by Lumbar Puncture (LP).
9. Severe visual or hearing impairment that would prevent the participant from performing psychometric tests accurately.
10. History of immunodeficiency disorders.
11. Participants with chronic viral hepatitis.
12. History of Tuberculosis (TB). Participants with no history of TB will be tested for previous TB exposure and a positive test will be exclusionary.
13. History of ophthalmic shingles or ocular Herpes Simplex Virus (HSV) infection.
14. Any live vaccine in the 3 months or any active infection within the last 4 weeks before study drug administration (that is, randomization).
15. Any chronic inflammatory disease that is not adequately controlled or requires immunosuppressive or immunomodulatory therapy.
16. T helper cell, cytotoxic T cell, or B cell absolute counts below normal.
17. Immunoglobulin (Ig) IgG, IgA, or IgM levels below normal at Screening or Baseline, unless both the Investigator and the Medical Monitor agree that the finding is not clinically significant.
18. Clinically significant deviation from normal in physical examination, vital signs, or clinical laboratory tests at Screening or Baseline.
19. Exclusionary cardiac factors include: prolonged QT interval greater than 450 millisecond from Electrocardiograms (ECGs); history of risk factors for torsade de pointes or the use of concomitant medications that prolong the QT/corrected QT interval (QTc); left bundle branch block; persistent low or high heart rate; persistent low or high blood pressure; history of cardiac arrhythmias; other clinically significant ECG abnormalities.
20. Type 1 or Type 2 diabetes mellitus that is not well controlled.
21. Malignant neoplasms within 5 years before Screening (except for basal or squamous cell carcinoma in situ of the skin, or localized prostate cancer that did not require systemic therapy; these do not exclude the participant).
22. Medical conditions (example, cardiac, respiratory, gastrointestinal, renal disease) that are not stably controlled, or which, in the opinion of the investigator(s), could affect the participant's safety or interfere with the study assessments.
23. Hypopigmentation conditions (example, albinism and vitiligo).
24. Known or suspected history of drug or alcohol dependency or abuse within 2 years, current use of recreational drugs or a positive urine drug test.
25. Planned surgery that requires general, spinal, or epidural anesthesia that would take place during the study.
26. Participation in any other interventional clinical study related to cognitive impairment within 6 months before Screening unless it can be documented that the participant was in a placebo treatment arm.
27. Currently enrolled in another clinical study or used any investigational drug or device within 60 days or 5 half-lives of the investigational medication (whichever is longer) proceeding informed consent.
28. Hypersensitivity to the study drug or any of the excipients or to other Beta Secretase Cleaving Enzyme (BACE) inhibitors, or to the PET tracer, or components of its formulation.
29. Females who are lactating or pregnant. Females of childbearing potential who do not agree to adhere to the protocol specified methods for avoiding pregnancy.
30. Males who do not meet the protocol requirements for avoiding their partners becoming pregnant. Sperm donation is not permitted.
Endpoints (40)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Coverage by outcome category
Global cognition
2 endpointsExtension Phase: Change From Extension Phase Baseline in the Mini-Mental State Examination (MMSE) Scores
Time frame:Baseline, at Month 3, at Month 6, at Month 9, at Month 12, at Month 15, at Month 18, at Month 21, at Month 24, at Month 28 and at Month 32
Mini-Mental State Examination (MMSE)
ratio, descriptive
Extension Phase: Change From Extension Phase Baseline in the Mini-Mental State Examination (MMSE) Scores
Time frame:Baseline, at Month 3, at Month 6, at Month 9, at Month 12, at Month 15, at Month 18, at Month 21, at Month 24, at Month 28 and at Month 32
Mini-Mental State Examination (MMSE)
ratio, descriptive
Posted result
| Group | Value (mean), score on a scale | Standard deviation |
|---|---|---|
| Extension Phase: Elenbecestat 50 mgBaselinen=41 Participants | 21.5 | 5.67 |
| Change at Month 3n=41 Participants | -0.6 | 2.32 |
| Change at Month 6n=39 Participants | -0.6 | 2.39 |
| Change at Month 9n=36 Participants | -0.9 | 2.89 |
| Change at Month 12n=36 Participants | -1.4 | 2.43 |
| Change at Month 15n=33 Participants | -1.8 | 2.78 |
| Change at Month 18n=32 Participants | -1.7 | 3.01 |
| Change at Month 21n=21 Participants | -2.5 | 3.27 |
| Change at Month 24n=10 Participants | -3.9 | 4.46 |
| Change at Month 28n=5 Participants | -6.4 | 4.28 |
| Change at Month 32n=1 Participants | -2.0 | NA |
Function / daily living
2 endpointsExtension Phase: Change From Extension Phase Baseline in the Functional Assessment Questionnaire (FAQ) Score
Time frame:Baseline, at Month 3, at Month 6, at Month 9, at Month 12, at Month 15, at Month 18, at Month 21, at Month 24, at Month 28 and at Month 32
descriptive
Extension Phase: Change From Extension Phase Baseline in the Functional Assessment Questionnaire (FAQ) Score
Time frame:Baseline, at Month 3, at Month 6, at Month 9, at Month 12, at Month 15, at Month 18, at Month 21, at Month 24, at Month 28 and at Month 32
descriptive
Posted result
| Group | Value (mean), score on a scale | Standard deviation |
|---|---|---|
| Extension Phase: Elenbecestat 50 mgBaselinen=41 Participants | 14.4 | 7.31 |
| Change at Month 3n=41 Participants | 1.3 | 5.51 |
| Change at Month 6n=39 Participants | 1.4 | 3.74 |
| Change at Month 9n=35 Participants | 2.2 | 4.33 |
| Change at Month 12n=36 Participants | 2.6 | 4.86 |
| Change at Month 15n=34 Participants | 3.0 | 5.17 |
| Change at Month 18n=32 Participants | 3.4 | 4.83 |
| Change at Month 21n=22 Participants | 3.0 | 3.88 |
| Change at Month 24n=10 Participants | 6.8 | 5.92 |
| Change at Month 28n=6 Participants | 9.2 | 4.67 |
| Change at Month 32n=1 Participants | 15.0 | NA |
Amyloid biomarkers
4 endpointsCore Phase: Percent Change From Baseline in Cerebrospinal Fluid (CSF) Amyloid (A) Beta(1-x) and Abeta(1-42) After 1 Month and 18 Months of Treatment
Time frame:Month 1 (Week 5) and Month 18 (Week 79)
percent change from baseline, improvement
Extension Phase: Percent Change From Extension Phase Baseline in Plasma Amyloid (A) Beta(1-x) Measurements at Months 12 and 24
Time frame:Month 12 and Month 24
percent change from baseline, improvement
Core Phase: Percent Change From Baseline in Cerebrospinal Fluid (CSF) Amyloid (A) Beta(1-x) and Abeta(1-42) After 1 Month and 18 Months of Treatment
Time frame:Month 1 (Week 5) and Month 18 (Week 79)
percent change from baseline, improvement
Posted result
| Group | Value (mean), percent change | Standard deviation |
|---|---|---|
| Core Phase: PlaceboPercent Change from Baseline in CSF Abeta(1-x) at Month 1 (Week 5)n=4 Participants | 6.63 | 12.545 |
| Percent Change from Baseline in CSF Abeta(1-x) at Month 18 (Week 79)n=1 Participants | -1.81 | NA |
| Percent Change from Baseline in CSF Abeta(1-42) at Month 1 (Week 5)n=4 Participants | -8.53 | 16.818 |
| Percent Change from Baseline in CSF Abeta(1-42) at Month 18 (Week 79)n=2 Participants | -6.50 | 24.809 |
| Core Phase: Elenbecestat 5 mg Then 50 mgPercent Change from Baseline in CSF Abeta(1-x) at Month 1 (Week 5)n=7 Participants | -18.16 | 17.873 |
| Percent Change from Baseline in CSF Abeta(1-x) at Month 18 (Week 79)n=2 Participants | -33.86 | 11.039 |
| Percent Change from Baseline in CSF Abeta(1-42) at Month 1 (Week 5)n=7 Participants | -9.43 | 22.798 |
| Percent Change from Baseline in CSF Abeta(1-42) at Month 18 (Week 79)n=2 Participants | -27.19 | 20.172 |
| Core Phase: Elenbecestat 15 mg Then 50 mgPercent Change from Baseline in CSF Abeta(1-x) at Month 1 (Week 5)n=6 Participants | -36.43 | 16.026 |
| Percent Change from Baseline in CSF Abeta(1-x) at Month 18 (Week 79)n=1 Participants | -0.71 | NA |
| Percent Change from Baseline in CSF Abeta(1-42) at Month 1 (Week 5)n=6 Participants | -20.69 | 15.488 |
| Percent Change from Baseline in CSF Abeta(1-42) at Month 18 (Week 79)n=3 Participants | -24.02 | 19.949 |
| Core Phase: Elenbecestat 50 mgPercent Change from Baseline in CSF Abeta(1-x) at Month 1 (Week 5)n=6 Participants | -56.66 | 14.431 |
| Percent Change from Baseline in CSF Abeta(1-x) at Month 18 (Week 79)n=2 Participants | 33.98 | 160.017 |
| Percent Change from Baseline in CSF Abeta(1-42) at Month 1 (Week 5)n=6 Participants | -38.89 | 16.378 |
| Percent Change from Baseline in CSF Abeta(1-42) at Month 18 (Week 79)n=4 Participants | -56.77 | 5.312 |
Extension Phase: Percent Change From Extension Phase Baseline in Plasma Amyloid (A) Beta(1-x) Measurements at Months 12 and 24
Time frame:Month 12 and Month 24
percent change from baseline, improvement
Posted result
| Group | Value (mean), percent change | Standard deviation |
|---|---|---|
| Extension Phase: Elenbecestat 50 mgPercent Change from Extension Phase Baseline in plasma Abeta(1-x) at Month 12n=27 Participants | -71.8 | 23.30 |
| Percent Change from Extension Phase Baseline in plasma Abeta(1-x) at Month 24n=5 Participants | -71.1 | 31.20 |
Neuroimaging
12 endpointsExtension Phase: Number of Participants With TEAEs and SAEs
Time frame:Up to 34 months
event count, event
Extension Phase: Number of Participants With TEAEs and SAEs
Time frame:Up to 34 months
event count, event
Posted result
| Group | Value (count_of_participants), Participants | Reported bounds |
|---|---|---|
| Extension Phase: Elenbecestat 50 mgTEAEsn=41 Participants | 30 | - |
| SAEsn=41 Participants | 6 | - |
Extension Phase: Number of Participants With Abnormal Magnetic Resonance Imaging (MRI) Findings
Time frame:Up to 34 months
event count, event
Extension Phase: Number of Participants With Abnormal Magnetic Resonance Imaging (MRI) Findings
Time frame:Up to 34 months
event count, event
Posted result
| Group | Value (count_of_participants), Participants | Reported bounds |
|---|---|---|
| Extension Phase: Elenbecestat 50 mgBrain Vasogenic Edeman=27 Participants | 0 | - |
| Brain Microhemorrhagesn=23 Participants | 4 | - |
| Brain White Matter Disease: Focal Lesionsn=27 Participants | 25 | - |
| Brain White Matter Disease: No Lesionsn=27 Participants | 2 | - |
| Area of superficial siderosisn=41 Participants | 1 | - |
| Space occupying lesion (extra axial): Meningioman=41 Participants | 1 | - |
| Other pituitary lesionn=41 Participants | 1 | - |
Extension Phase: Percent Change From Extension Phase Baseline in Total Hippocampal Volume at Month 24
Time frame:Month 24
percent change from baseline, improvement
Extension Phase: Percent Change From Extension Phase Baseline in Left and Right Hippocampal Volume at Month 24
Time frame:Month 24
percent change from baseline, improvement
Extension Phase: Percent Change From Extension Phase Baseline in Whole Brain Volume at Month 24
Time frame:Month 24
percent change from baseline, improvement
Extension Phase: Percent Change From Extension Phase Baseline in Total Ventricular Volume at Month 24
Time frame:Month 24
percent change from baseline, improvement
Extension Phase: Percent Change From Extension Phase Baseline in Total Hippocampal Volume at Month 24
Time frame:Month 24
percent change from baseline, improvement
Posted result
| Group | Value (mean), percent change | Standard deviation |
|---|---|---|
| Extension Phase: Elenbecestat 50 mgn=12 Participants | -4.33 | 2.080 |
Extension Phase: Percent Change From Extension Phase Baseline in Left and Right Hippocampal Volume at Month 24
Time frame:Month 24
percent change from baseline, improvement
Posted result
| Group | Value (mean), percent change | Standard deviation |
|---|---|---|
| Extension Phase: Elenbecestat 50 mgPercent Change at Month 24 (Left Hippocampal Volume)n=12 Participants | -4.31 | 2.065 |
| Percent Change at Month 24 (Right Hippocampal Volume)n=12 Participants | -4.37 | 2.667 |
Extension Phase: Percent Change From Extension Phase Baseline in Whole Brain Volume at Month 24
Time frame:Month 24
percent change from baseline, improvement
Posted result
| Group | Value (mean), percent change | Standard deviation |
|---|---|---|
| Extension Phase: Elenbecestat 50 mgn=12 Participants | -3.26 | 1.555 |
Extension Phase: Percent Change From Extension Phase Baseline in Total Ventricular Volume at Month 24
Time frame:Month 24
percent change from baseline, improvement
Posted result
| Group | Value (mean), percent change | Standard deviation |
|---|---|---|
| Extension Phase: Elenbecestat 50 mgn=12 Participants | 15.18 | 8.544 |
Fluid / digital biomarkers
2 endpointsCore Phase: Mean Concentration of Elenbecestat in CSF
Time frame:Month 1 (Week 5) and Month 18 (Week 79)
concentration, descriptive
Core Phase: Mean Concentration of Elenbecestat in CSF
Time frame:Month 1 (Week 5) and Month 18 (Week 79)
concentration, descriptive
Posted result
| Group | Value (mean), nanogram per milliliter (ng/mL) | Standard deviation |
|---|---|---|
| Core Phase: Elenbecestat 5 mg Then 50 mgMonth 1 (Week 5)n=7 Participants | 1.10 | 0.438 |
| Month 18 (Week 79)n=2 Participants | 0.10 | 0 |
| Core Phase: Elenbecestat 15 mg Then 50 mgMonth 1 (Week 5)n=6 Participants | 3.71 | 1.360 |
| Month 18 (Week 79)n=2 Participants | 2.72 | 3.197 |
| Core Phase: Elenbecestat 50 mgMonth 1 (Week 5)n=6 Participants | 9.93 | 3.568 |
| Month 18 (Week 79)n=4 Participants | 14.46 | 3.411 |
Safety / tolerability / PK
14 endpointsCore Phase: Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Time frame:Up to 21 months
event count, event
Core Phase: Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Time frame:Up to 21 months
event count, event
Posted result
| Group | Value (count_of_participants), Participants | Reported bounds |
|---|---|---|
| Core Phase: Placebon=17 Participants | 15 | - |
| Core Phase: Elenbecestat 5 mg Then 50 mgn=17 Participants | 15 | - |
| Core Phase: Elenbecestat 15 mg Then 50 mgn=19 Participants | 18 | - |
| Core Phase: Elenbecestat 50 mgn=17 Participants | 15 | - |
Core Phase: Number of Participants With Serious Adverse Events (SAEs)
Time frame:Up to 21 months
event count, event
Core Phase: Number of Participants With Serious Adverse Events (SAEs)
Time frame:Up to 21 months
event count, event
Posted result
| Group | Value (count_of_participants), Participants | Reported bounds |
|---|---|---|
| Core Phase: Placebon=17 Participants | 2 | - |
| Core Phase: Elenbecestat 5 mg Then 50 mgn=17 Participants | 2 | - |
| Core Phase: Elenbecestat 15 mg Then 50 mgn=19 Participants | 5 | - |
| Core Phase: Elenbecestat 50 mgn=17 Participants | 1 | - |
Core Phase: Number of Participants With Treatment Emergent Markedly Abnormal Laboratory Safety Test Values
Time frame:Up to 21 months
event count, event
Core Phase: Number of Participants With Treatment Emergent Markedly Abnormal Laboratory Safety Test Values
Time frame:Up to 21 months
event count, event
Posted result
| Group | Value (count_of_participants), Participants | Reported bounds |
|---|---|---|
| Core Phase: PlaceboMarkedly Abnormal Low: Lymphocytesn=17 Participants | 0 | - |
| Markedly Abnormal Low: Leukocytesn=17 Participants | 1 | - |
| Markedly Abnormal Low: Neutrophilsn=17 Participants | 1 | - |
| Markedly Abnormal Low: Hemoglobinn=17 Participants | 1 | - |
| Markedly Abnormal Low: Calciumn=17 Participants | 1 | - |
| Markedly Abnormal Low: Potassiumn=17 Participants | 0 | - |
| Markedly Abnormal High: Potassiumn=17 Participants | 2 | - |
| Markedly Abnormal High: Alkaline Phosphatasen=17 Participants | 0 | - |
| Markedly Abnormal High: Alanine Aminotransferasen=17 Participants | 1 | - |
| Markedly Abnormal High: Aspartate Aminotransferasen=17 Participants | 0 | - |
| Markedly Abnormal High: Gamma Glutamyl Transferasen=17 Participants | 1 | - |
| Markedly Abnormal Low: Glucosen=17 Participants | 0 | - |
| Markedly Abnormal High: Glucosen=17 Participants | 2 | - |
| Markedly Abnormal High: Cholesteroln=17 Participants | 1 | - |
| Markedly Abnormal High: Triglyceridesn=17 Participants | 1 | - |
| Markedly Abnormal High: Creatininen=17 Participants | 0 | - |
| Core Phase: Elenbecestat 5 mg Then 50 mgMarkedly Abnormal Low: Lymphocytesn=17 Participants | 2 | - |
| Markedly Abnormal Low: Leukocytesn=17 Participants | 0 | - |
| Markedly Abnormal Low: Neutrophilsn=17 Participants | 0 | - |
| Markedly Abnormal Low: Hemoglobinn=17 Participants | 0 | - |
| Markedly Abnormal Low: Calciumn=17 Participants | 0 | - |
| Markedly Abnormal Low: Potassiumn=17 Participants | 0 | - |
| Markedly Abnormal High: Potassiumn=17 Participants | 4 | - |
| Markedly Abnormal High: Alkaline Phosphatasen=17 Participants | 0 | - |
| Markedly Abnormal High: Alanine Aminotransferasen=17 Participants | 0 | - |
| Markedly Abnormal High: Aspartate Aminotransferasen=17 Participants | 0 | - |
| Markedly Abnormal High: Gamma Glutamyl Transferasen=17 Participants | 0 | - |
| Markedly Abnormal Low: Glucosen=17 Participants | 1 | - |
| Markedly Abnormal High: Glucosen=17 Participants | 4 | - |
| Markedly Abnormal High: Cholesteroln=17 Participants | 0 | - |
| Markedly Abnormal High: Triglyceridesn=17 Participants | 1 | - |
| Markedly Abnormal High: Creatininen=17 Participants | 2 | - |
| Core Phase: Elenbecestat 15 mg Then 50 mgMarkedly Abnormal Low: Lymphocytesn=19 Participants | 0 | - |
| Markedly Abnormal Low: Leukocytesn=19 Participants | 0 | - |
| Markedly Abnormal Low: Neutrophilsn=19 Participants | 0 | - |
| Markedly Abnormal Low: Hemoglobinn=19 Participants | 0 | - |
| Markedly Abnormal Low: Calciumn=19 Participants | 0 | - |
| Markedly Abnormal Low: Potassiumn=19 Participants | 1 | - |
| Markedly Abnormal High: Potassiumn=19 Participants | 2 | - |
| Markedly Abnormal High: Alkaline Phosphatasen=19 Participants | 0 | - |
| Markedly Abnormal High: Alanine Aminotransferasen=19 Participants | 0 | - |
| Markedly Abnormal High: Aspartate Aminotransferasen=19 Participants | 0 | - |
| Markedly Abnormal High: Gamma Glutamyl Transferasen=19 Participants | 0 | - |
| Markedly Abnormal Low: Glucosen=19 Participants | 0 | - |
| Markedly Abnormal High: Glucosen=19 Participants | 1 | - |
| Markedly Abnormal High: Cholesteroln=19 Participants | 0 | - |
| Markedly Abnormal High: Triglyceridesn=19 Participants | 3 | - |
| Markedly Abnormal High: Creatininen=19 Participants | 0 | - |
| Core Phase: Elenbecestat 50 mgMarkedly Abnormal Low: Lymphocytesn=17 Participants | 0 | - |
| Markedly Abnormal Low: Leukocytesn=17 Participants | 0 | - |
| Markedly Abnormal Low: Neutrophilsn=17 Participants | 1 | - |
| Markedly Abnormal Low: Hemoglobinn=17 Participants | 0 | - |
| Markedly Abnormal Low: Calciumn=17 Participants | 0 | - |
| Markedly Abnormal Low: Potassiumn=17 Participants | 0 | - |
| Markedly Abnormal High: Potassiumn=17 Participants | 0 | - |
| Markedly Abnormal High: Alkaline Phosphatasen=17 Participants | 1 | - |
| Markedly Abnormal High: Alanine Aminotransferasen=17 Participants | 1 | - |
| Markedly Abnormal High: Aspartate Aminotransferasen=17 Participants | 1 | - |
| Markedly Abnormal High: Gamma Glutamyl Transferasen=17 Participants | 1 | - |
| Markedly Abnormal Low: Glucosen=17 Participants | 0 | - |
| Markedly Abnormal High: Glucosen=17 Participants | 1 | - |
| Markedly Abnormal High: Cholesteroln=17 Participants | 0 | - |
| Markedly Abnormal High: Triglyceridesn=17 Participants | 2 | - |
| Markedly Abnormal High: Creatininen=17 Participants | 0 | - |
Core Phase: Number of Participants With Markedly Abnormal Vital Sign Values
Time frame:Month 0(Baseline,Week 2,Week 3,Week 4);Month 1(Week 5,Week 7);Month 2(Week 9,Week 11);Month 3(Week 13);Month 4(Week 17);Month 5(Week 21);Month 6(Week 27);Month 9(Week 40);Month 12(Week 53);Month 15(Week 66);Month 18(Week 79) and Follow-up at Month 1 and 3
event count, event
Core Phase: Number of Participants With Markedly Abnormal Vital Sign Values
Time frame:Month 0(Baseline,Week 2,Week 3,Week 4);Month 1(Week 5,Week 7);Month 2(Week 9,Week 11);Month 3(Week 13);Month 4(Week 17);Month 5(Week 21);Month 6(Week 27);Month 9(Week 40);Month 12(Week 53);Month 15(Week 66);Month 18(Week 79) and Follow-up at Month 1 and 3
event count, event
Posted result
| Group | Value (count_of_participants), Participants | Reported bounds |
|---|---|---|
| Core Phase: PlaceboMarkedly Abnormal Low: Temperature (Month 0: Baseline)n=17 Participants | 0 | - |
| Markedly Abnormal Low: Temperature (Month 0: Week 2)n=16 Participants | 0 | - |
| Markedly Abnormal Low: Temperature (Month 0: Week 3)n=17 Participants | 2 | - |
| Markedly Abnormal Low: Temperature (Month 0: Week 4)n=17 Participants | 1 | - |
| Markedly Abnormal High: Temperature (Month 0: Week 4)n=17 Participants | 0 | - |
| Markedly Abnormal Low: Temperature (Month 1: Week 5)n=17 Participants | 1 | - |
| Markedly Abnormal Low: Temperature (Month 1: Week 7)n=17 Participants | 0 | - |
| Markedly Abnormal Low: Temperature (Month 2: Week 9)n=17 Participants | 0 | - |
| Markedly Abnormal Low: Temperature (Month 2: Week 11)n=16 Participants | 1 | - |
| Markedly Abnormal Low: Temperature (Month 3: Week 13)n=16 Participants | 1 | - |
| Markedly Abnormal Low: Temperature (Month 4: Week 17)n=15 Participants | 1 | - |
| Markedly Abnormal Low: Temperature (Month 5: Week 21)n=15 Participants | 1 | - |
| Markedly Abnormal Low: Temperature (Month 6: Week 27)n=15 Participants | 0 | - |
| Markedly Abnormal Low: Temperature (Month 9: Week 40)n=14 Participants | 1 | - |
| Markedly Abnormal Low: Temperature (Month 12: Week 53)n=13 Participants | 0 | - |
| Markedly Abnormal Low: Temperature (Month 15: Week 66)n=13 Participants | 0 | - |
| Markedly Abnormal Low: Temperature (Month 18: Week 79)n=12 Participants | 0 | - |
| Markedly Abnormal Low: Temperature (Follow-up: Month 1)n=13 Participants | 0 | - |
| Markedly Abnormal Low: Temperature (Follow-up: Month 3)n=12 Participants | 0 | - |
| Markedly Abnormal Low: Weight (Month 0: Baseline)n=17 Participants | 0 | - |
| Markedly Abnormal High: Weight (Month 0: Baseline)n=17 Participants | 1 | - |
| Markedly Abnormal High: Weight (Month 3: Week 13)n=16 Participants | 0 | - |
| Markedly Abnormal High: Weight (Month 6: Week 27)n=14 Participants | 0 | - |
| Markedly Abnormal High: Weight (Month 9: Week 40)n=13 Participants | 0 | - |
| Markedly Abnormal High: Weight (Follow-up: Month 3)n=10 Participants | 0 | - |
| Markedly Abnormal High: Systolic Blood Pressure (Month 0: Baseline)n=17 Participants | 0 | - |
| Markedly Abnormal High: Systolic Blood Pressure (Month 0: Week 2)n=16 Participants | 1 | - |
| Markedly Abnormal High: Systolic Blood Pressure (Month 0: Week 3)n=17 Participants | 1 | - |
| Markedly Abnormal High: Systolic Blood Pressure (Month 0: Week 4)n=17 Participants | 1 | - |
| Markedly Abnormal High: Systolic Blood Pressure (Month 1: Week 5)n=17 Participants | 1 | - |
| Markedly Abnormal High: Systolic Blood Pressure (Month 1: Week 7)n=17 Participants | 0 | - |
| Markedly Abnormal High: Systolic Blood Pressure (Month 3: Week 13)n=16 Participants | 0 | - |
| Markedly Abnormal High: Systolic Blood Pressure (Month 4: Week 17)n=15 Participants | 1 | - |
| Markedly Abnormal High: Systolic Blood Pressure (Month 6: Week 27)n=15 Participants | 0 | - |
| Markedly Abnormal High: Systolic Blood Pressure (Month 9: Week 40)n=14 Participants | 0 | - |
| Markedly Abnormal High: Systolic Blood Pressure (Month 12: Week 53)n=13 Participants | 0 | - |
| Markedly Abnormal High: Systolic Blood Pressure (Month 15: Week 66)n=13 Participants | 1 | - |
| Markedly Abnormal High: Systolic Blood Pressure (Month 18: Week 79)n=12 Participants | 0 | - |
| Markedly Abnormal High: Systolic Blood Pressure (Follow-up: Month 1)n=13 Participants | 1 | - |
| Markedly Abnormal High: Systolic Blood Pressure (Follow-up: Month 3)n=12 Participants | 0 | - |
| Markedly Abnormal High: Diastolic Blood Pressure (Month 0: Week 3)n=17 Participants | 1 | - |
| Markedly Abnormal Low: Diastolic Blood Pressure (Month 0: Week 4)n=17 Participants | 1 | - |
| Markedly Abnormal Low: Diastolic Blood Pressure (Month 1: Week 5)n=17 Participants | 0 | - |
| Markedly Abnormal Low: Diastolic Blood Pressure (Month 9: Week 40)n=14 Participants | 0 | - |
| Markedly Abnormal High: Diastolic Blood Pressure (Month 9: Week 40)n=14 Participants | 1 | - |
| Markedly Abnormal High: Diastolic Blood Pressure (Follow-up: Month 1)n=13 Participants | 1 | - |
| Markedly Abnormal High: Diastolic Blood Pressure (Follow-up: Month 3)n=12 Participants | 0 | - |
| Core Phase: Elenbecestat 5 mg Then 50 mgMarkedly Abnormal Low: Temperature (Month 0: Baseline)n=17 Participants | 2 | - |
| Markedly Abnormal Low: Temperature (Month 0: Week 2)n=17 Participants | 0 | - |
| Markedly Abnormal Low: Temperature (Month 0: Week 3)n=17 Participants | 1 | - |
| Markedly Abnormal Low: Temperature (Month 0: Week 4)n=17 Participants | 3 | - |
| Markedly Abnormal High: Temperature (Month 0: Week 4)n=17 Participants | 0 | - |
| Markedly Abnormal Low: Temperature (Month 1: Week 5)n=17 Participants | 0 | - |
| Markedly Abnormal Low: Temperature (Month 1: Week 7)n=17 Participants | 1 | - |
| Markedly Abnormal Low: Temperature (Month 2: Week 9)n=17 Participants | 1 | - |
| Markedly Abnormal Low: Temperature (Month 2: Week 11)n=16 Participants | 1 | - |
| Markedly Abnormal Low: Temperature (Month 3: Week 13)n=16 Participants | 2 | - |
| Markedly Abnormal Low: Temperature (Month 4: Week 17)n=16 Participants | 3 | - |
| Markedly Abnormal Low: Temperature (Month 5: Week 21)n=16 Participants | 3 | - |
| Markedly Abnormal Low: Temperature (Month 6: Week 27)n=15 Participants | 1 | - |
| Markedly Abnormal Low: Temperature (Month 9: Week 40)n=13 Participants | 2 | - |
| Markedly Abnormal Low: Temperature (Month 12: Week 53)n=12 Participants | 1 | - |
| Markedly Abnormal Low: Temperature (Month 15: Week 66)n=11 Participants | 3 | - |
| Markedly Abnormal Low: Temperature (Month 18: Week 79)n=11 Participants | 1 | - |
| Markedly Abnormal Low: Temperature (Follow-up: Month 1)n=12 Participants | 0 | - |
| Markedly Abnormal Low: Temperature (Follow-up: Month 3)n=11 Participants | 2 | - |
| Markedly Abnormal Low: Weight (Month 0: Baseline)n=17 Participants | 0 | - |
| Markedly Abnormal High: Weight (Month 0: Baseline)n=17 Participants | 3 | - |
| Markedly Abnormal High: Weight (Month 3: Week 13)n=16 Participants | 2 | - |
| Markedly Abnormal High: Weight (Month 6: Week 27)n=15 Participants | 1 | - |
| Markedly Abnormal High: Weight (Month 9: Week 40)n=13 Participants | 0 | - |
| Markedly Abnormal High: Weight (Follow-up: Month 3)n=12 Participants | 1 | - |
| Markedly Abnormal High: Systolic Blood Pressure (Month 0: Baseline)n=17 Participants | 0 | - |
| Markedly Abnormal High: Systolic Blood Pressure (Month 0: Week 2)n=17 Participants | 0 | - |
| Markedly Abnormal High: Systolic Blood Pressure (Month 0: Week 3)n=17 Participants | 0 | - |
| Markedly Abnormal High: Systolic Blood Pressure (Month 0: Week 4)n=17 Participants | 0 | - |
| Markedly Abnormal High: Systolic Blood Pressure (Month 1: Week 5)n=17 Participants | 0 | - |
| Markedly Abnormal High: Systolic Blood Pressure (Month 1: Week 7)n=17 Participants | 1 | - |
| Markedly Abnormal High: Systolic Blood Pressure (Month 3: Week 13)n=16 Participants | 0 | - |
| Markedly Abnormal High: Systolic Blood Pressure (Month 4: Week 17)n=16 Participants | 0 | - |
| Markedly Abnormal High: Systolic Blood Pressure (Month 6: Week 27)n=15 Participants | 0 | - |
| Markedly Abnormal High: Systolic Blood Pressure (Month 9: Week 40)n=13 Participants | 0 | - |
| Markedly Abnormal High: Systolic Blood Pressure (Month 12: Week 53)n=12 Participants | 1 | - |
| Markedly Abnormal High: Systolic Blood Pressure (Month 15: Week 66)n=11 Participants | 1 | - |
| Markedly Abnormal High: Systolic Blood Pressure (Month 18: Week 79)n=11 Participants | 1 | - |
| Markedly Abnormal High: Systolic Blood Pressure (Follow-up: Month 1)n=12 Participants | 0 | - |
| Markedly Abnormal High: Systolic Blood Pressure (Follow-up: Month 3)n=11 Participants | 0 | - |
| Markedly Abnormal High: Diastolic Blood Pressure (Month 0: Week 3)n=17 Participants | 0 | - |
| Markedly Abnormal Low: Diastolic Blood Pressure (Month 0: Week 4)n=17 Participants | 1 | - |
| Markedly Abnormal Low: Diastolic Blood Pressure (Month 1: Week 5)n=17 Participants | 0 | - |
| Markedly Abnormal Low: Diastolic Blood Pressure (Month 9: Week 40)n=13 Participants | 1 | - |
| Markedly Abnormal High: Diastolic Blood Pressure (Month 9: Week 40)n=13 Participants | 0 | - |
| Markedly Abnormal High: Diastolic Blood Pressure (Follow-up: Month 1)n=12 Participants | 0 | - |
| Markedly Abnormal High: Diastolic Blood Pressure (Follow-up: Month 3)n=11 Participants | 0 | - |
| Core Phase: Elenbecestat 15 mg Then 50 mgMarkedly Abnormal Low: Temperature (Month 0: Baseline)n=19 Participants | 0 | - |
| Markedly Abnormal Low: Temperature (Month 0: Week 2)n=19 Participants | 2 | - |
| Markedly Abnormal Low: Temperature (Month 0: Week 3)n=19 Participants | 4 | - |
| Markedly Abnormal Low: Temperature (Month 0: Week 4)n=19 Participants | 1 | - |
| Markedly Abnormal High: Temperature (Month 0: Week 4)n=19 Participants | 1 | - |
| Markedly Abnormal Low: Temperature (Month 1: Week 5)n=19 Participants | 2 | - |
| Markedly Abnormal Low: Temperature (Month 1: Week 7)n=18 Participants | 3 | - |
| Markedly Abnormal Low: Temperature (Month 2: Week 9)n=15 Participants | 1 | - |
| Markedly Abnormal Low: Temperature (Month 2: Week 11)n=15 Participants | 1 | - |
| Markedly Abnormal Low: Temperature (Month 3: Week 13)n=15 Participants | 3 | - |
| Markedly Abnormal Low: Temperature (Month 4: Week 17)n=13 Participants | 1 | - |
| Markedly Abnormal Low: Temperature (Month 5: Week 21)n=13 Participants | 0 | - |
| Markedly Abnormal Low: Temperature (Month 6: Week 27)n=12 Participants | 0 | - |
| Markedly Abnormal Low: Temperature (Month 9: Week 40)n=11 Participants | 0 | - |
| Markedly Abnormal Low: Temperature (Month 12: Week 53)n=11 Participants | 1 | - |
| Markedly Abnormal Low: Temperature (Month 15: Week 66)n=10 Participants | 2 | - |
| Markedly Abnormal Low: Temperature (Month 18: Week 79)n=10 Participants | 0 | - |
| Markedly Abnormal Low: Temperature (Follow-up: Month 1)n=15 Participants | 2 | - |
| Markedly Abnormal Low: Temperature (Follow-up: Month 3)n=12 Participants | 4 | - |
| Markedly Abnormal Low: Weight (Month 0: Baseline)n=19 Participants | 1 | - |
| Markedly Abnormal High: Weight (Month 0: Baseline)n=19 Participants | 2 | - |
| Markedly Abnormal High: Weight (Month 3: Week 13)n=15 Participants | 2 | - |
| Markedly Abnormal High: Weight (Month 6: Week 27)n=12 Participants | 1 | - |
| Markedly Abnormal High: Weight (Month 9: Week 40)n=11 Participants | 0 | - |
| Markedly Abnormal High: Weight (Follow-up: Month 3)n=14 Participants | 1 | - |
| Markedly Abnormal High: Systolic Blood Pressure (Month 0: Baseline)n=19 Participants | 0 | - |
| Markedly Abnormal High: Systolic Blood Pressure (Month 0: Week 2)n=19 Participants | 0 | - |
| Markedly Abnormal High: Systolic Blood Pressure (Month 0: Week 3)n=19 Participants | 0 | - |
| Markedly Abnormal High: Systolic Blood Pressure (Month 0: Week 4)n=19 Participants | 0 | - |
| Markedly Abnormal High: Systolic Blood Pressure (Month 1: Week 5)n=19 Participants | 0 | - |
| Markedly Abnormal High: Systolic Blood Pressure (Month 1: Week 7)n=18 Participants | 0 | - |
| Markedly Abnormal High: Systolic Blood Pressure (Month 3: Week 13)n=15 Participants | 0 | - |
| Markedly Abnormal High: Systolic Blood Pressure (Month 4: Week 17)n=13 Participants | 0 | - |
| Markedly Abnormal High: Systolic Blood Pressure (Month 6: Week 27)n=12 Participants | 1 | - |
| Markedly Abnormal High: Systolic Blood Pressure (Month 9: Week 40)n=11 Participants | 1 | - |
| Markedly Abnormal High: Systolic Blood Pressure (Month 12: Week 53)n=11 Participants | 1 | - |
| Markedly Abnormal High: Systolic Blood Pressure (Month 15: Week 66)n=10 Participants | 0 | - |
| Markedly Abnormal High: Systolic Blood Pressure (Month 18: Week 79)n=10 Participants | 1 | - |
| Markedly Abnormal High: Systolic Blood Pressure (Follow-up: Month 1)n=15 Participants | 1 | - |
| Markedly Abnormal High: Systolic Blood Pressure (Follow-up: Month 3)n=12 Participants | 0 | - |
| Markedly Abnormal High: Diastolic Blood Pressure (Month 0: Week 3)n=19 Participants | 0 | - |
| Markedly Abnormal Low: Diastolic Blood Pressure (Month 0: Week 4)n=19 Participants | 0 | - |
| Markedly Abnormal Low: Diastolic Blood Pressure (Month 1: Week 5)n=19 Participants | 0 | - |
| Markedly Abnormal Low: Diastolic Blood Pressure (Month 9: Week 40)n=11 Participants | 0 | - |
| Markedly Abnormal High: Diastolic Blood Pressure (Month 9: Week 40)n=11 Participants | 0 | - |
| Markedly Abnormal High: Diastolic Blood Pressure (Follow-up: Month 1)n=15 Participants | 0 | - |
| Markedly Abnormal High: Diastolic Blood Pressure (Follow-up: Month 3)n=12 Participants | 0 | - |
| Core Phase: Elenbecestat 50 mgMarkedly Abnormal Low: Temperature (Month 0: Baseline)n=17 Participants | 2 | - |
| Markedly Abnormal Low: Temperature (Month 0: Week 2)n=17 Participants | 2 | - |
| Markedly Abnormal Low: Temperature (Month 0: Week 3)n=16 Participants | 0 | - |
| Markedly Abnormal Low: Temperature (Month 0: Week 4)n=17 Participants | 1 | - |
| Markedly Abnormal High: Temperature (Month 0: Week 4)n=17 Participants | 0 | - |
| Markedly Abnormal Low: Temperature (Month 1: Week 5)n=17 Participants | 0 | - |
| Markedly Abnormal Low: Temperature (Month 1: Week 7)n=16 Participants | 0 | - |
| Markedly Abnormal Low: Temperature (Month 2: Week 9)n=16 Participants | 2 | - |
| Markedly Abnormal Low: Temperature (Month 2: Week 11)n=16 Participants | 2 | - |
| Markedly Abnormal Low: Temperature (Month 3: Week 13)n=16 Participants | 1 | - |
| Markedly Abnormal Low: Temperature (Month 4: Week 17)n=16 Participants | 1 | - |
| Markedly Abnormal Low: Temperature (Month 5: Week 21)n=16 Participants | 0 | - |
| Markedly Abnormal Low: Temperature (Month 6: Week 27)n=16 Participants | 1 | - |
| Markedly Abnormal Low: Temperature (Month 9: Week 40)n=15 Participants | 1 | - |
| Markedly Abnormal Low: Temperature (Month 12: Week 53)n=12 Participants | 0 | - |
| Markedly Abnormal Low: Temperature (Month 15: Week 66)n=12 Participants | 2 | - |
| Markedly Abnormal Low: Temperature (Month 18: Week 79)n=12 Participants | 1 | - |
| Markedly Abnormal Low: Temperature (Follow-up: Month 1)n=14 Participants | 0 | - |
| Markedly Abnormal Low: Temperature (Follow-up: Month 3)n=14 Participants | 0 | - |
| Markedly Abnormal Low: Weight (Month 0: Baseline)n=17 Participants | 0 | - |
| Markedly Abnormal High: Weight (Month 0: Baseline)n=17 Participants | 1 | - |
| Markedly Abnormal High: Weight (Month 3: Week 13)n=16 Participants | 2 | - |
| Markedly Abnormal High: Weight (Month 6: Week 27)n=15 Participants | 1 | - |
| Markedly Abnormal High: Weight (Month 9: Week 40)n=14 Participants | 1 | - |
| Markedly Abnormal High: Weight (Follow-up: Month 3)n=14 Participants | 0 | - |
| Markedly Abnormal High: Systolic Blood Pressure (Month 0: Baseline)n=17 Participants | 1 | - |
| Markedly Abnormal High: Systolic Blood Pressure (Month 0: Week 2)n=17 Participants | 0 | - |
| Markedly Abnormal High: Systolic Blood Pressure (Month 0: Week 3)n=16 Participants | 0 | - |
| Markedly Abnormal High: Systolic Blood Pressure (Month 0: Week 4)n=17 Participants | 0 | - |
| Markedly Abnormal High: Systolic Blood Pressure (Month 1: Week 5)n=17 Participants | 0 | - |
| Markedly Abnormal High: Systolic Blood Pressure (Month 1: Week 7)n=16 Participants | 0 | - |
| Markedly Abnormal High: Systolic Blood Pressure (Month 3: Week 13)n=16 Participants | 1 | - |
| Markedly Abnormal High: Systolic Blood Pressure (Month 4: Week 17)n=16 Participants | 0 | - |
| Markedly Abnormal High: Systolic Blood Pressure (Month 6: Week 27)n=16 Participants | 1 | - |
| Markedly Abnormal High: Systolic Blood Pressure (Month 9: Week 40)n=15 Participants | 1 | - |
| Markedly Abnormal High: Systolic Blood Pressure (Month 12: Week 53)n=12 Participants | 1 | - |
| Markedly Abnormal High: Systolic Blood Pressure (Month 15: Week 66)n=12 Participants | 1 | - |
| Markedly Abnormal High: Systolic Blood Pressure (Month 18: Week 79)n=12 Participants | 1 | - |
| Markedly Abnormal High: Systolic Blood Pressure (Follow-up: Month 1)n=14 Participants | 1 | - |
| Markedly Abnormal High: Systolic Blood Pressure (Follow-up: Month 3)n=14 Participants | 1 | - |
| Markedly Abnormal High: Diastolic Blood Pressure (Month 0: Week 3)n=16 Participants | 0 | - |
| Markedly Abnormal Low: Diastolic Blood Pressure (Month 0: Week 4)n=17 Participants | 0 | - |
| Markedly Abnormal Low: Diastolic Blood Pressure (Month 1: Week 5)n=17 Participants | 1 | - |
| Markedly Abnormal Low: Diastolic Blood Pressure (Month 9: Week 40)n=15 Participants | 0 | - |
| Markedly Abnormal High: Diastolic Blood Pressure (Month 9: Week 40)n=15 Participants | 0 | - |
| Markedly Abnormal High: Diastolic Blood Pressure (Follow-up: Month 1)n=14 Participants | 0 | - |
| Markedly Abnormal High: Diastolic Blood Pressure (Follow-up: Month 3)n=14 Participants | 1 | - |
Core Phase: Number of Participants With Markedly Abnormal Electrocardiogram (ECG) Findings
Time frame:Up to 21 months
event count, event
Core Phase: Number of Participants With Markedly Abnormal Electrocardiogram (ECG) Findings
Time frame:Up to 21 months
event count, event
Posted result
| Group | Value (count_of_participants), Participants | Reported bounds |
|---|---|---|
| Core Phase: PlaceboAt least one post-baseline increase of >30 millisecond (msec) in QTcF intervaln=17 Participants | 2 | - |
| At least one post-baseline value of >450 msec in QTcF intervaln=17 Participants | 1 | - |
| At least one post-baseline value of >480 msec in QTcF intervaln=17 Participants | 0 | - |
| Core Phase: Elenbecestat 5 mg Then 50 mgAt least one post-baseline increase of >30 millisecond (msec) in QTcF intervaln=17 Participants | 4 | - |
| At least one post-baseline value of >450 msec in QTcF intervaln=17 Participants | 6 | - |
| At least one post-baseline value of >480 msec in QTcF intervaln=17 Participants | 0 | - |
| Core Phase: Elenbecestat 15 mg Then 50 mgAt least one post-baseline increase of >30 millisecond (msec) in QTcF intervaln=19 Participants | 4 | - |
| At least one post-baseline value of >450 msec in QTcF intervaln=19 Participants | 4 | - |
| At least one post-baseline value of >480 msec in QTcF intervaln=19 Participants | 1 | - |
| Core Phase: Elenbecestat 50 mgAt least one post-baseline increase of >30 millisecond (msec) in QTcF intervaln=17 Participants | 2 | - |
| At least one post-baseline value of >450 msec in QTcF intervaln=17 Participants | 3 | - |
| At least one post-baseline value of >480 msec in QTcF intervaln=17 Participants | 0 | - |
Extension Phase: Number of Participants With Markedly Abnormal Vital Sign Values
Time frame:Up to 34 months
event count, event
Extension Phase: Number of Participants With Markedly Abnormal Vital Sign Values
Time frame:Up to 34 months
event count, event
Posted result
| Group | Value (count_of_participants), Participants | Reported bounds |
|---|---|---|
| Extension Phase: Elenbecestat 50 mgMarkedly Abnormal High: Diastolic Blood Pressuren=41 Participants | 1 | - |
| Markedly Abnormal Low: Diastolic Blood Pressuren=41 Participants | 1 | - |
| Markedly Abnormal High: Systolic Blood Pressuren=41 Participants | 5 | - |
| Markedly Abnormal High: Temperaturen=41 Participants | 1 | - |
| Markedly Abnormal Low: Temperaturen=41 Participants | 10 | - |
| Markedly Abnormal High: Weightn=41 Participants | 1 | - |
Extension Phase: Number of Participants With Treatment Emergent Markedly Abnormal Laboratory Safety Test Values
Time frame:Up to 34 months
event count, event
Extension Phase: Number of Participants With Treatment Emergent Markedly Abnormal Laboratory Safety Test Values
Time frame:Up to 34 months
event count, event
Posted result
| Group | Value (count_of_participants), Participants | Reported bounds |
|---|---|---|
| Extension Phase: Elenbecestat 50 mgMarkedly Abnormal Low: Lymphocytesn=41 Participants | 4 | - |
| Markedly Abnormal Low: Neutrophilsn=41 Participants | 2 | - |
| Markedly Abnormal Low: Hemoglobinn=41 Participants | 1 | - |
| Markedly Abnormal High: Potassiumn=41 Participants | 4 | - |
| Markedly Abnormal High: Alanine Aminotransferasen=41 Participants | 1 | - |
| Markedly Abnormal High: Gamma Glutamyl Transferasen=41 Participants | 2 | - |
| Markedly Abnormal High: Glucosen=41 Participants | 3 | - |
| Markedly Abnormal High: Triglyceridesn=41 Participants | 2 | - |
| Markedly Abnormal High: Creatininen=41 Participants | 4 | - |
| Markedly Abnormal High: Uraten=41 Participants | 1 | - |
| Markedly Abnormal Low: Plateletsn=41 Participants | 1 | - |
Other (unclassified)
4 endpointsExtension Phase: Number of Participants With Markedly Abnormal ECG Findings
Time frame:Up to 34 months
event count, event
Extension Phase: Number of Participants With Markedly Abnormal ECG Findings
Time frame:Up to 34 months
event count, event
Posted result
| Group | Value (count_of_participants), Participants | Reported bounds |
|---|---|---|
| Extension Phase: Elenbecestat 50 mgAt least one post-baseline increase of >30 msec in QTcF intervaln=41 Participants | 2 | - |
| At least one post-baseline value of >450 msec in QTcF intervaln=41 Participants | 4 | - |
Core Phase: Mean Concentration of Elenbecestat in Plasma
Time frame:Month 0 (Week 3), Month 3 (Week 13), Month 6 (Week 27), Month 12 (Week 53): Pre-dose, 1 to 6 hours Post-dose; Month 1 (Week 5), Month 18 (Week 79): Pre-dose, 4 to 8 hours Post-dose
concentration, descriptive
Core Phase: Mean Concentration of Elenbecestat in Plasma
Time frame:Month 0 (Week 3), Month 3 (Week 13), Month 6 (Week 27), Month 12 (Week 53): Pre-dose, 1 to 6 hours Post-dose; Month 1 (Week 5), Month 18 (Week 79): Pre-dose, 4 to 8 hours Post-dose
concentration, descriptive
Posted result
| Group | Value (mean), ng/mL | Standard deviation |
|---|---|---|
| Core Phase: Elenbecestat 5 mg Then 50 mgMonth 0 (Week 3): Pre-dosen=17 Participants | 1.43 | 1.105 |
| Month 0 (Week 3): 1 to 6 hours Post-dosen=17 Participants | 4.28 | 3.185 |
| Month 1 (Week 5): Pre-dosen=15 Participants | 1.47 | 0.870 |
| Month 1 (Week 5): 4 to 8 hours Post-dosen=16 Participants | 4.80 | 2.529 |
| Month 3 (Week 13): Pre-dosen=16 Participants | 1.91 | 1.703 |
| Month 3 (Week 13): 1 to 6 hours Post-dosen=16 Participants | 6.06 | 2.456 |
| Month 6 (Week 27): Pre-dosen=15 Participants | 2.34 | 2.196 |
| Month 6 (Week 27): 1 to 6 hours Post-dosen=15 Participants | 11.11 | 15.322 |
| Month 12 (Week 53): Pre-dosen=11 Participants | 13.84 | 18.482 |
| Month 12 (Week 53): 1 to 6 hours Post-dosen=12 Participants | 49.78 | 40.656 |
| Month 18 (Week 79): Pre-dosen=10 Participants | 7.88 | 5.896 |
| Month 18 (Week 79): 4 to 8 hours Post-dosen=9 Participants | 47.16 | 28.651 |
| Core Phase: Elenbecestat 15 mg Then 50 mgMonth 0 (Week 3): Pre-dosen=18 Participants | 5.81 | 3.785 |
| Month 0 (Week 3): 1 to 6 hours Post-dosen=18 Participants | 18.49 | 11.272 |
| Month 1 (Week 5): Pre-dosen=19 Participants | 6.74 | 4.246 |
| Month 1 (Week 5): 4 to 8 hours Post-dosen=19 Participants | 19.59 | 7.940 |
| Month 3 (Week 13): Pre-dosen=15 Participants | 6.90 | 8.126 |
| Month 3 (Week 13): 1 to 6 hours Post-dosen=14 Participants | 20.35 | 8.893 |
| Month 6 (Week 27): Pre-dosen=11 Participants | 9.10 | 9.018 |
| Month 6 (Week 27): 1 to 6 hours Post-dosen=12 Participants | 25.49 | 22.247 |
| Month 12 (Week 53): Pre-dosen=10 Participants | 21.03 | 30.897 |
| Month 12 (Week 53): 1 to 6 hours Post-dosen=10 Participants | 58.38 | 65.148 |
| Month 18 (Week 79): Pre-dosen=8 Participants | 7.13 | 6.990 |
| Month 18 (Week 79): 4 to 8 hours Post-dosen=8 Participants | 51.99 | 44.656 |
| Core Phase: Elenbecestat 50 mgMonth 0 (Week 3): Pre-dosen=13 Participants | 15.77 | 11.281 |
| Month 0 (Week 3): 1 to 6 hours Post-dosen=13 Participants | 70.41 | 37.681 |
| Month 1 (Week 5): Pre-dosen=15 Participants | 15.46 | 10.463 |
| Month 1 (Week 5): 4 to 8 hours Post-dosen=16 Participants | 66.83 | 21.370 |
| Month 3 (Week 13): Pre-dosen=16 Participants | 12.31 | 7.007 |
| Month 3 (Week 13): 1 to 6 hours Post-dosen=16 Participants | 75.15 | 27.852 |
| Month 6 (Week 27): Pre-dosen=15 Participants | 12.03 | 8.962 |
| Month 6 (Week 27): 1 to 6 hours Post-dosen=15 Participants | 71.28 | 39.114 |
| Month 12 (Week 53): Pre-dosen=11 Participants | 16.74 | 22.804 |
| Month 12 (Week 53): 1 to 6 hours Post-dosen=11 Participants | 82.55 | 56.084 |
| Month 18 (Week 79): Pre-dosen=12 Participants | 19.21 | 13.602 |
| Month 18 (Week 79): 4 to 8 hours Post-dosen=11 Participants | 70.43 | 22.500 |
Provenance
Sources
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.