CompletedPhase 1 / PHASE2Results posted

A Study to Assess Safety and Target Engagement of E2814 in Participants With Mild to Moderate Cognitive Impairment Due to Dominantly Inherited Alzheimer's Disease

An Open-Label Phase 1b/2 Study to Assess Safety and Target Engagement of E2814 in Subjects With Mild to Moderate Cognitive Impairment Due to Dominantly Inherited Alzheimer's Disease

Lead sponsor

Eisai Inc.

Asset

E2814

Listed sites

Recruiting sites

Enrollment

actual

Study population

Alzheimer’s disease

Key I/E criteria

•PSEN1/PSEN2/APP mutation required•Amyloid biomarker required•CDR-SB 5-12•Study partner/caregiver required•MRI contraindications excluded

Primary endpoints

•Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs•Markedly Abnormal Laboratory Values•Vital Signs 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

Eudract number2020-005728-12

Org study IDE2814-G000-103

NCT IDNCT04971733

Timeline

Milestones

Study start2021-06-28actual

Study first posted2021-07-21actual

Primary completion2024-05-24actual

Study completion2024-05-24actual

Last update posted2025-06-10actual

Results first posted2025-06-10actual

Assets

Drug assets

E2814

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age18 Years

Maximum age80 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

1. Male or female, age 18 to 80 years at the time of informed consent

2. Individuals who are confirmed to be mutation positive for presenilin 1 (PSEN1), amyloid precursor protein (APP), or presenilin 2 (PSEN2) gene that is associated with DIAD

3. Clinical Dementia Rating - Sum of Boxes (CDR-SB) score 5 to 12 at Screening

4. Able to undergo magnetic resonance imaging (MRI), lumbar puncture (LP), PET, and complete all study-related testing and evaluations

5. Has a study partner who in the investigator's judgment is able to provide accurate information as to the participant's cognitive and functional abilities, who agrees to provide information at the study visits which require informant input for scale completion

Exclusion criteria

1. Clinically significant illness that required medical treatment within 8 weeks before the 1st dose or a clinically significant infection that required medical treatment within 4 weeks before 1st dose

2. Females who are breastfeeding or pregnant at Screening or Baseline

3. Females of childbearing potential who:

Within 3 months before screening, did not use a highly effective method of contraception

4. Any neurological condition that may be contributing to cognitive impairment above and beyond that caused by the participant's Alzheimer's disease (AD)

5. History of transient ischemic attacks, stroke, or seizures within 12 months of Screening

6. History of clinically important carotid or vertebrobasilar stenosis, plaque, or other prominent risk factor for stroke or cerebral haemorrhage (including atrial fibrillation and anticoagulation). Low dose aspirin (less than or equal to [<=] 325 milligram [mg] daily) is not exclusionary

7. Any current psychiatric diagnosis or symptoms, (example, hallucinations, major depression, or delusions) that could interfere with study procedures in the participant

8. Geriatric Depression Scale (GDS) score greater than or equal to 8 at Screening

9. Contraindications to MRI scanning, including but not limited to pacemaker/cardiac defibrillator, neurostimulators, ferromagnetic metal implants (example, in skull and cardiac devices other than those approved as safe for use in MRI scanners)

10. Evidence of other clinically significant lesions on brain MRI at Screening that could indicate a dementia diagnosis other than AD

11. Other significant pathological findings on brain MRI at Screening

12. Hypersensitivity to E2814 or any of the excipients, or to any monoclonal antibody (mAb) treatment

13. Any immunological disease which is not adequately controlled, or which requires treatment with immunoglobulins, systemic monoclonal antibodies (or derivatives of monoclonal antibodies), systemic immunosuppressants, or plasmapheresis during the study

14. With a bleeding disorder of current chronic use of anticoagulants (example, warfarin, dabigatran, rivaroxaban or apixaban) or of clopidogrel is exclusionary. Limited (occasional or isolated) use of anticoagulants/antiplatelet compounds in cases such as surgical procedures

15. Have thyroid stimulating hormone outside of normal range. Other tests of thyroid function with results outside the normal range should only be exclusionary if they are considered clinically significant by the investigator

16. Hemoglobin A1c (HgbA1c) greater than (>) 8 percent (%) (retesting is permitted if slightly elevated) or poorly controlled insulin-dependent diabetes (including hypoglycemic episodes). Participants may be rescreened after 3 months to allow optimization of diabetic control

17. Abnormally low serum vitamin B12 levels for the testing laboratory

18. History of human immunodeficiency virus (HIV) infection, history of hepatitis B infection within the past year, history of hepatitis C infection which has not been adequately treated, or history of spirochete infection of the central nervous system (example, syphilis, Lyme, or borreliosis)

19. Any other clinically significant abnormalities in physical examination, vital signs, laboratory tests, or ECG at Screening or Baseline which in the opinion of the investigator require further investigation or treatment or which may interfere with study procedures or safety

20. Malignant neoplasms within 3 years of Screening (except for basal or squamous cell carcinoma in situ of the skin, or localized prostate cancer in male participant, or localized breast cancer in female participants)

21. Answers "yes" to Columbia-Suicide Severity Rating Scale (C-SSRS) suicidal ideation Type 4 or 5, or any suicidal behavior assessment within 6 months before Screening, at Screening, or at the Baseline Visit, or has been hospitalized or treated for any suicidal behavior in lifetime

22. Known or suspected history of drug or alcohol abuse or dependence within 2 years before Screening or a positive urine drug test at Screening

23. Any other medical conditions (example, cardiac, respiratory, gastrointestinal, renal disease) which are not stably and adequately controlled, or which in the opinion of the investigator could affect the participant's safety or interfere with the study assessments

24. Concurrent participation in a clinical study involving any anti-amyloid therapies (including any mAb therapies) within 6 months before Screening

25. Concurrent participation in a clinical study involving any anti-tau therapies

26. Participated in any other investigational medication or device study in the 3 months or 5 half-lives (whichever is longer) of the medication before Screening

27. Planned surgery which requires general anesthesia that would take place during the study

28. Visual or hearing impairment that would prevent the participant from performing psychometric tests accurately

Endpoints (36)

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

Safety / tolerability / PK

Fluid / digital biomarkers

Tau biomarkers

Other (unclassified)

Neuroimaging

Tau biomarkers

4 endpoints

Secondary/protocol endpoint

Cohort A: Change From Baseline in CSF Concentrations of Phosphorylated Tau (P-tau) 181, 205, and 217

Time frame:Baseline, and pre-dose at Days 84, 169, 253, 421, 505, 589, and 757

change from baseline, improvement

Secondary/protocol endpoint

Cohort A: Change From Baseline in Ratio of CSF Concentrations of p-Tau/Non-phosphorylated (np) Tau for 181, 217, and 205

Time frame:Baseline, and pre-dose at Days 84, 169, 253, 421, 505, 589, and 757

change from baseline, improvement

Secondary/registry result

Cohort A: Change From Baseline in CSF Concentrations of Phosphorylated Tau (P-tau) 181, 205, and 217

Time frame:Baseline, and pre-dose at Days 84, 169, 253, 421, 505, 589, and 757

change from baseline, improvement

Posted result

Group	Value (mean), pg/mL	Standard deviation
Cohort A: E2814 750 mgChange in P-tau 181 at Day 84: Predosen=2 Participants	-166.50	33.177
Change in P-tau 205 at Day 84: Predosen=2 Participants	-38.37	26.736
Change in P-tau 217 at Day 84: Predosen=2 Participants	-190.56	120.537
Cohort A: E2814 1500 mgChange in P-tau 181 at Day 84: Predosen=5 Participants	2.41	204.061
Change in P-tau 181 at Day 169: Predosen=3 Participants	-10.32	131.136
Change in P-tau 205 at Day 84: Predosen=5 Participants	-14.70	101.226
Change in P-tau 205 at Day 169: Predosen=3 Participants	-67.43	126.128
Change in P-tau 217 at Day 84: Predosen=5 Participants	-216.52	258.741
Change in P-tau 217 at Day 169: Predosen=3 Participants	-294.28	350.271
Cohort A: E2814 3000 mgChange in P-tau 181 at Day 169: Predosen=3 Participants	-249.82	351.972
Change in P-tau 181 at Day 253: Predosen=5 Participants	-308.74	443.284
Change in P-tau 181 at Day 421: Predosen=2 Participants	-84.85	106.021
Change in P-tau 205 at Day 169: Predosen=3 Participants	-34.19	86.949
Change in P-tau 205 at Day 253: Predosen=5 Participants	-84.42	71.648
Change in P-tau 205 at Day 421: Predosen=2 Participants	-25.26	4.975
Change in P-tau 217 at Day 169: Predosen=3 Participants	-188.49	47.791
Change in P-tau 217 at Day 253: Predosen=5 Participants	-375.74	246.487
Change in P-tau 217 at Day 421: Predosen=2 Participants	-217.44	134.880
Cohort A: E2814 4500 mgChange in P-tau 181 at Day 421: Predosen=1 Participants	-1032.26	NA
Change in P-tau 181 at Day 505: Predosen=1 Participants	-50.49	NA
Change in P-tau 181 at Day 589: Predosen=1 Participants	-106.21	NA
Change in P-tau 181 at Day 757: Predosen=2 Participants	-606.64	561.342
Change in P-tau 205 at Day 421: Predosen=1 Participants	-113.91	NA
Change in P-tau 205 at Day 505: Predosen=1 Participants	-24.12	NA
Change in P-tau 205 at Day 589: Predosen=1 Participants	4.48	NA
Change in P-tau 205 at Day 757: Predosen=2 Participants	-73.59	58.215
Change in P-tau 217 at Day 421: Predosen=1 Participants	-680.92	NA
Change in P-tau 217 at Day 505: Predosen=1 Participants	-368.02	NA
Change in P-tau 217 at Day 589: Predosen=1 Participants	-135.13	NA
Change in P-tau 217 at Day 757: Predosen=2 Participants	-422.60	335.717

Secondary/registry result

Cohort A: Change From Baseline in Ratio of CSF Concentrations of p-Tau/Non-phosphorylated (np) Tau for 181, 217, and 205

Time frame:Baseline, and pre-dose at Days 84, 169, 253, 421, 505, 589, and 757

change from baseline, improvement

Posted result

Group	Value (mean), ratio	Standard deviation
Cohort A: E2814 750 mgChange in P-tau181/np-tau181 ratio at Day 84: Predosen=2 Participants	0.95	2.463
Change in P-tau205/np-tau205 ratio at Day 84: Predosen=2 Participants	0.42	0.950
Change in P-tau217/np-tau217 ratio at Day 84: Predosen=2 Participants	-3.03	4.624
Cohort A: E2814 1500 mgChange in P-tau181/np-tau181 ratio at Day 84: Predosen=5 Participants	10.21	12.187
Change in P-tau181/np-tau181 ratio at Day 169: Predosen=3 Participants	17.54	16.734
Change in P-tau205/np-tau205 ratio at Day 84: Predosen=5 Participants	3.51	2.221
Change in P-tau205/np-tau205 ratio at Day 169: Predosen=3 Participants	2.08	0.525
Change in P-tau217/np-tau217 ratio at Day 84: Predosen=5 Participants	-5.49	4.240
Change in P-tau217/np-tau217 ratio at Day 169: Predosen=3 Participants	-8.13	5.564
Cohort A: E2814 3000 mgChange in P-tau181/np-tau181 ratio at Day 169: Predosen=3 Participants	-8.88	15.713
Change in P-tau181/np-tau181 ratio at Day 253: Predosen=5 Participants	2.96	12.693
Change in P-tau181/np-tau181 ratio at Day 421: Predosen=2 Participants	3.23	4.146
Change in P-tau205/np-tau205 ratio at Day 169: Predosen=3 Participants	0.86	4.695
Change in P-tau205/np-tau205 ratio at Day 253: Predosen=5 Participants	2.53	1.647
Change in P-tau205/np-tau205 ratio at Day 421: Predosen=2 Participants	1.16	0.915
Change in P-tau217/np-tau217 ratio at Day 169: Predosen=3 Participants	-8.48	6.258
Change in P-tau217/np-tau217 ratio at Day 253: Predosen=5 Participants	-10.74	5.265
Change in P-tau217/np-tau217 ratio at Day 421: Predosen=2 Participants	-10.16	4.143
Cohort A: E2814 4500 mgChange in P-tau181/np-tau181 ratio at Day 421: Predosen=1 Participants	-8.78	NA
Change in P-tau181/np-tau181 ratio at Day 505: Predosen=1 Participants	11.64	NA
Change in P-tau181/np-tau181 ratio at Day 589: Predosen=1 Participants	0.40	NA
Change in P-tau181/np-tau181 ratio at Day 757: Predosen=2 Participants	-6.87	7.470
Change in P-tau205/np-tau205 ratio at Day 421: Predosen=1 Participants	4.53	NA
Change in P-tau205/np-tau205 ratio at Day 505: Predosen=1 Participants	2.32	NA
Change in P-tau205/np-tau205 ratio at Day 589: Predosen=1 Participants	2.02	NA
Change in P-tau205/np-tau205 ratio at Day 757: Predosen=2 Participants	1.80	0.035
Change in P-tau217/np-tau217 ratio at Day 421: Predosen=1 Participants	-15.35	NA
Change in P-tau217/np-tau217 ratio at Day 505: Predosen=1 Participants	-16.05	NA
Change in P-tau217/np-tau217 ratio at Day 589: Predosen=1 Participants	-8.52	NA
Change in P-tau217/np-tau217 ratio at Day 757: Predosen=2 Participants	-14.56	5.138

Neuroimaging

2 endpoints

Secondary/protocol endpoint

Cohort A: Change From Baseline in Tau Positron Emission Tomography (PET) Standardized Uptake Value Ratio (SUVR) by Region

Time frame:Baseline, at Weeks 60 and 108

change from baseline, improvement

Secondary/registry result

Cohort A: Change From Baseline in Tau Positron Emission Tomography (PET) Standardized Uptake Value Ratio (SUVR) by Region

Time frame:Baseline, at Weeks 60 and 108

change from baseline, improvement

Posted result

Group	Value (mean), SUVR	Standard deviation
Cohort A: E2814 4500 mgChange in PET tau SUVR in Cingulate Region at Week 60n=3 Participants	0.135	0.3756
Change in PET tau SUVR in Cingulate Region at Week 108n=3 Participants	0.296	0.4628
Change in PET tau SUVR in Frontal Region at Week 60n=3 Participants	0.138	1.0103
Change in PET tau SUVR in Frontal Region at Week 108n=3 Participants	0.159	0.9609
Change in PET tau SUVR in Medial Temporal Region at Week 60n=3 Participants	0.165	0.5615
Change in PET tau SUVR in Medial Temporal Region at Week 108n=3 Participants	0.071	0.5421
Change in PET tau SUVR in Occipital Region at Week 60n=3 Participants	0.258	0.9359
Change in PET tau SUVR in Occipital Region at Week 108n=3 Participants	0.320	0.8409
Change in PET tau SUVR in Parietal Region at Week 60n=3 Participants	0.124	0.9826
Change in PET tau SUVR in Parietal Region at Week 108n=3 Participants	0.017	0.8415
Change in PET tau SUVR in Temporal Region at Week 60n=3 Participants	0.218	0.9283
Change in PET tau SUVR in Temporal Region at Week 108n=3 Participants	0.093	0.7699
Change in PET tau SUVR in Meta-Temporal Region at Week 60n=3 Participants	0.179	0.9515
Change in PET tau SUVR in Meta-Temporal Region at Week 108n=3 Participants	0.014	0.7942
Change in PET tau SUVR in Whole Cortical Gray Matter (GM) Region at Week 60n=3 Participants	0.172	0.9461
Change in PET tau SUVR in Whole Cortical GM Region at Week 108n=3 Participants	0.133	0.8421

Fluid / digital biomarkers

6 endpoints

Primary/protocol endpoint

Cohort A: Change From Baseline in Cerebrospinal Fluid (CSF) Free, CSF Bound and Total Microtubule Binding Region of Tau (MTBR-tau; Starting at Amino Acid 354 and 299) at 12 Weeks

Time frame:Pre-dose at Week 12

change from baseline, improvement

Primary/registry result

Cohort A: Change From Baseline in Cerebrospinal Fluid (CSF) Free, CSF Bound and Total Microtubule Binding Region of Tau (MTBR-tau; Starting at Amino Acid 354 and 299) at 12 Weeks

Time frame:Pre-dose at Week 12

change from baseline, improvement

Posted result

Group	Value (mean), nanogram per milliliter (ng/mL)	Standard deviation
Cohort A: E2814 750 mgChange in CSF Free MTBR-tau354n=7 Participants	-0.0534	0.0690
Change in CSF Free MTBR-tau299n=7 Participants	-0.0147	0.0267
Change in CSF Bound MTBR-tau354n=7 Participants	0.178	0.0886
Change in CSF Bound MTBR-tau299n=7 Participants	0.0420	0.0194
Change in CSF Total MTBR-tau354n=7 Participants	0.125	0.0899
Change in CSF Total MTBR-tau299n=7 Participants	0.0273	0.0191

Secondary/protocol endpoint

Cohort A: CSF Concentrations of E2814

Time frame:Pre-dose at Days 1, 84, 85, 169, 253, 421, and 757

concentration, descriptive

Secondary/protocol endpoint

Cohort A: Change From Baseline in CSF Concentrations of Total MTBR-tau243

Time frame:Baseline, and pre-dose at Days 84, 169, 253, 421, 505, 589, and 757

change from baseline, improvement

Secondary/registry result

Cohort A: CSF Concentrations of E2814

Time frame:Pre-dose at Days 1, 84, 85, 169, 253, 421, and 757

concentration, descriptive

Posted result

Group	Value (mean), ng/mL	Standard deviation
Cohort A: E2814 750 mgDay 1: Pre-dosen=7 Participants	0	0
Day 84: Pre-dosen=2 Participants	172	77.8
Day 85: Pre-dosen=5 Participants	153	32.2
Cohort A: E2814 1500 mgDay 169: Pre-dosen=7 Participants	429	212
Cohort A: E2814 3000 mgDay 253: Pre-dosen=5 Participants	806	426
Day 421: Pre-dosen=2 Participants	1035	35.4
Cohort A: E2814 4500 mgDay 757: Pre-dosen=2 Participants	1611	1567

Secondary/registry result

Cohort A: Change From Baseline in CSF Concentrations of Total MTBR-tau243

Time frame:Baseline, and pre-dose at Days 84, 169, 253, 421, 505, 589, and 757

change from baseline, improvement

Posted result

Group	Value (mean), picogram per milliliter (pg/mL)	Standard deviation
Cohort A: E2814 750 mgChange at Day 84: Pre-dosen=2 Participants	-210	156
Cohort A: E2814 1500 mgChange at Day 84: Pre-dosen=5 Participants	-139	53.5
Change at Day 169: Pre-dosen=1 Participants	-151	NA
Cohort A: E2814 3000 mgChange at Day 169: Pre-dosen=3 Participants	-236	88.3
Change at Day 253: Pre-dosen=4 Participants	-296	232
Change at Day 421: Pre-dosen=2 Participants	-216	127
Cohort A: E2814 4500 mgChange at Day 505: Pre-dosen=1 Participants	-315	NA
Change at Day 589: Pre-dosen=1 Participants	-147	NA
Change at Day 757: Pre-dosen=2 Participants	-381	377

Safety / tolerability / PK

20 endpoints

Primary/protocol endpoint

Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs

Time frame:From first dose of study drug up to 120 weeks

event count, event

Primary/protocol endpoint

Number of Participants With Markedly Abnormal Laboratory Values

Time frame:From first dose of study drug up to 120 weeks

event count, event

Primary/protocol endpoint

Number of Participants With Clinically Significant Change in Vital Signs Values

Time frame:From first dose of study drug up to 120 weeks

change from baseline, event

Primary/protocol endpoint

Number of Participants With Clinically Significant Change in Electrocardiogram (ECG) Findings

Time frame:From first dose of study drug up to 120 weeks

change from baseline, event

Primary/registry result

Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs

Time frame:From first dose of study drug up to 120 weeks

event count, event

Posted result

Group	Value (count_of_participants), Participants	Reported bounds
Cohort A: E2814 750 mgTEAEsn=7 Participants	4	-
Serious TEAEsn=7 Participants	0	-
Cohort A: E2814 1500 mgTEAEsn=7 Participants	1	-
Serious TEAEsn=7 Participants	0	-
Cohort A+B: E2814 3000 mgTEAEsn=8 Participants	8	-
Serious TEAEsn=8 Participants	2	-
Cohort A: E2814 4500 mgTEAEsn=4 Participants	4	-
Serious TEAEsn=4 Participants	1	-

Primary/registry result

Number of Participants With Markedly Abnormal Laboratory Values

Time frame:From first dose of study drug up to 120 weeks

event count, event

Posted result

Group	Value (count_of_participants), Participants	Reported bounds
Cohort A: E2814 750 mgn=7 Participants	0	-
Cohort A: E2814 1500 mgn=7 Participants	1	-
Cohort A+B: E2814 3000 mgn=8 Participants	1	-
Cohort A: E2814 4500 mgn=4 Participants	2	-

Primary/registry result

Number of Participants With Clinically Significant Change in Vital Signs Values

Time frame:From first dose of study drug up to 120 weeks

change from baseline, event

Posted result

Group	Value (count_of_participants), Participants	Reported bounds
Cohort A: E2814 750 mgn=7 Participants	0	-
Cohort A: E2814 1500 mgn=7 Participants	0	-
Cohort A+B: E2814 3000 mgn=8 Participants	0	-
Cohort A: E2814 4500 mgn=4 Participants	0	-

Primary/registry result

Number of Participants With Clinically Significant Change in Electrocardiogram (ECG) Findings

Time frame:From first dose of study drug up to 120 weeks

change from baseline, event

Posted result

Group	Value (count_of_participants), Participants	Reported bounds
Cohort A: E2814 750 mgn=7 Participants	0	-
Cohort A: E2814 1500 mgn=7 Participants	0	-
Cohort A+B: E2814 3000 mgn=8 Participants	0	-
Cohort A: E2814 4500 mgn=4 Participants	0	-

Secondary/protocol endpoint

Cohort A, Cmax: Maximum Observed Plasma Concentration for E2814

Time frame:Cohort A, E2814 750 mg: Day 1 pre-dose up to 25 hours post-dose; Cohort A, E2814 1500 mg: Day 85 pre-dose up to 25 hours post-dose

concentration, descriptive

Secondary/protocol endpoint

Cohort A, Tmax: Time to Reach the Maximum Plasma Concentration for E2814

Time frame:Cohort A, E2814 750 mg: Day 1 pre-dose up to 25 hours post-dose; Cohort A, E2814 1500 mg: Day 85 pre-dose up to 25 hours post-dose

time to event, event

Secondary/protocol endpoint

Cohort A, AUC(0-672h): Area Under the Plasma Concentration-time Curve From Zero Time to 672 Hours for E2814

Time frame:Cohort A, E2814 750 mg: Day 1 pre-dose up to 672 hours post-dose; Cohort A, E2814 1500 mg: Day 85 pre-dose up to 672 hours post-dose

time to event, event

Secondary/protocol endpoint

Cohort A, Cmax: Maximum Observed Serum Concentration for E2814

Time frame:Cohort A, E2814 750 mg: Day 1 pre-dose up to 25 hours post-dose; Cohort A, E2814 1500 mg: Day 85 pre-dose up to 25 hours post-dose

concentration, descriptive

Secondary/protocol endpoint

Cohort A, Tmax: Time to Reach the Maximum Serum Concentration for E2814

Time frame:Cohort A, E2814 750 mg: Day 1 pre-dose up to 25 hours post-dose; Cohort A, E2814 1500 mg: Day 85 pre-dose up to 25 hours post-dose

time to event, event

Secondary/protocol endpoint

Cohort A, AUC(0-672h): Area Under the Serum Concentration-time Curve From Zero Time to 672 Hours for E2814

Time frame:Cohort A, E2814 750 mg: Day 1 pre-dose up to 672 hours post-dose; Cohort A, E2814 1500 mg: Day 85 pre-dose up to 672 hours post-dose

time to event, event

Secondary/registry result

Cohort A, Cmax: Maximum Observed Plasma Concentration for E2814

Time frame:Cohort A, E2814 750 mg: Day 1 pre-dose up to 25 hours post-dose; Cohort A, E2814 1500 mg: Day 85 pre-dose up to 25 hours post-dose

concentration, descriptive

Posted result

Group	Value (geometric_mean), microgram per milliliter (mcg/mL)	Geometric coefficient of variation
Cohort A: E2814 750 mgn=7 Participants	218	25.9
Cohort A: E2814 1500 mgn=7 Participants	499	24.3

Secondary/registry result

Cohort A, Tmax: Time to Reach the Maximum Plasma Concentration for E2814

Time frame:Cohort A, E2814 750 mg: Day 1 pre-dose up to 25 hours post-dose; Cohort A, E2814 1500 mg: Day 85 pre-dose up to 25 hours post-dose

time to event, event

Posted result

Group	Value (median), hours	Reported bounds
Cohort A: E2814 750 mgn=7 Participants	1.00	-1.00 - 5.00
Cohort A: E2814 1500 mgn=7 Participants	1.00	-1.00 - 5.00

Secondary/registry result

Cohort A, AUC(0-672h): Area Under the Plasma Concentration-time Curve From Zero Time to 672 Hours for E2814

Time frame:Cohort A, E2814 750 mg: Day 1 pre-dose up to 672 hours post-dose; Cohort A, E2814 1500 mg: Day 85 pre-dose up to 672 hours post-dose

time to event, event

Posted result

Group	Value (geometric_mean), hourmicrogram per milliliter (hmcg/mL)	Geometric coefficient of variation
Cohort A: E2814 750 mgn=7 Participants	66500	23.2

Secondary/registry result

Cohort A, Cmax: Maximum Observed Serum Concentration for E2814

Time frame:Cohort A, E2814 750 mg: Day 1 pre-dose up to 25 hours post-dose; Cohort A, E2814 1500 mg: Day 85 pre-dose up to 25 hours post-dose

concentration, descriptive

Posted result

Group	Value (geometric_mean), mcg/mL	Geometric coefficient of variation
Cohort A: E2814 750 mgn=7 Participants	41.7	64.1
Cohort A: E2814 1500 mgn=7 Participants	101	47.1

Secondary/registry result

Cohort A, Tmax: Time to Reach the Maximum Serum Concentration for E2814

Time frame:Cohort A, E2814 750 mg: Day 1 pre-dose up to 25 hours post-dose; Cohort A, E2814 1500 mg: Day 85 pre-dose up to 25 hours post-dose

time to event, event

Posted result

Group	Value (median), hours	Reported bounds
Cohort A: E2814 750 mgn=7 Participants	1.00	-1.00 - 25.00
Cohort A: E2814 1500 mgn=7 Participants	5.00	-1.00 - 9.00

Secondary/registry result

Cohort A, AUC(0-672h): Area Under the Serum Concentration-time Curve From Zero Time to 672 Hours for E2814

Time frame:Cohort A, E2814 750 mg: Day 1 pre-dose up to 672 hours post-dose; Cohort A, E2814 1500 mg: Day 85 pre-dose up to 672 hours post-dose

time to event, event

Posted result

Group	Value (geometric_mean), h*mcg/mL	Geometric coefficient of variation
Cohort A: E2814 750 mgn=7 Participants	8030	54.8

Other (unclassified)

4 endpoints

Secondary/protocol endpoint/low confidence

Number of Participants With Treatment-emergent Positive Serum Anti-E2814 Antibody

Time frame:From first dose of study drug up to 120 weeks

event count, event

Secondary/protocol endpoint/low confidence

Number of Participants With Treatment-emergent Positive Plasma Anti-E2814 Antibody

Time frame:From first dose of study drug up to 120 weeks

event count, event

Secondary/registry result/low confidence

Number of Participants With Treatment-emergent Positive Serum Anti-E2814 Antibody

Time frame:From first dose of study drug up to 120 weeks

event count, event

Posted result

Group	Value (count_of_participants), Participants	Reported bounds
Cohort A: E2814 750 mgn=7 Participants	1	-
Cohort A: E2814 1500 mgn=7 Participants	1	-
Cohort A+B: E2814 3000 mgn=6 Participants	0	-
Cohort A: E2814 4500 mgn=3 Participants	0	-

Secondary/registry result/low confidence

Number of Participants With Treatment-emergent Positive Plasma Anti-E2814 Antibody

Time frame:From first dose of study drug up to 120 weeks

event count, event

Posted result

Group	Value (count_of_participants), Participants	Reported bounds
Cohort A: E2814 750 mgn=7 Participants	1	-
Cohort A: E2814 1500 mgn=7 Participants	1	-
Cohort A+B: E2814 3000 mgn=6 Participants	1	-
Cohort A: E2814 4500 mgn=3 Participants	1	-

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Andreozzi E, Yagi T, Wildsmith K, Rawal S, Horie K, Boyd P, Takahashi E, Barthelemy NR, Aluri J, Charil A, Reilhac A, Gordon BA, Flores S, Verbel D, Sauter N, Benzinger TLS, McDade E, Mummery C; Dominantly Inherited Alzheimer Network (DIAN); Dominantly Inherited Alzheimer Network Trials Unit (DIAN-TU); Zhou J, Bateman RJ, Reyderman L. Etalanetug (E2814) in dominantly inherited Alzheimer's disease: an open-label phase 1b/2 study to assess safety and target engagement in participants with mild…
PMID41964075via DERIVED

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableClinicalTrials.gov results section

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.