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A Study to Evaluate the Safety and Efficacy of CT1812 in Subjects With Mild to Moderate Alzheimer's Disease.
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 2 Study to Evaluate the Safety and Efficacy of CT1812 in Subjects With Mild to Moderate Alzheimer's Disease.
Lead sponsor
Asset
CT1812
Listed sites
32
Recruiting sites
-
Enrollment
153
actual
Study population
Alzheimer’s disease
Key I/E criteria
•mild-to-moderate AD•Amyloid biomarker required (PET/CSF)•MMSE 18-26
Primary endpoints
•Number of Study Participants With at Least One Mild, Moderate•Number of Study Participants With at Least One Treatment Emergent Adverse
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
1. Men, and women of non-childbearing potential, 50-85 years of age inclusively, with a diagnosis of mild to moderate Alzheimer's disease according to the 2011 NIA-AA criteria and at least a 6 month decline in cognitive function documented in the medical record.
i) Non-childbearing potential for women is defined as postmenopausal (last natural menses greater than 24 months) or undergone a documented bilateral tubal ligation or hysterectomy. If last natural menses less than 24 months, a serum FSH value confirming post-menopausal status can be employed.
ii) Male participants who are sexually active with a woman of child-bearing potential must agree to use condoms during the trial and for 3 months after last dose unless the woman is using an acceptable means of birth control. Acceptable forms of birth control include abstinence, birth control pills, or any double combination of: intrauterine device (IUD), male or female condom, diaphragm, sponge, and cervical cap.
2. Diagnostic confirmation by amyloid PET with florbetaben or another approved amyloid PET ligand. Previous amyloid imaging study with a positive result will be accepted. If none is available, then amyloid PET will be conducted during screening. Diagnostic confirmation by a CSF sample collected at the screening visit lumbar puncture in place of amyloid PET will also be acceptable
3. Neuroimaging (MRI) obtained during screening consistent with the clinical diagnosis of Alzheimer's disease and without findings of significant exclusionary abnormalities (see exclusion criteria, number 4). An historical MRI, up to 1 year prior to screening, may be used as long as there is no history of intervening neurologic disease or clinical events (such as a stroke, head trauma etc.) and the subject is without clinical symptoms or signs suggestive of such intervening events.).
4. MMSE 18-26 inclusive
Exclusion criteria
1. Screening MRI (or historical MRI, if applicable) of the brain indicative of significant abnormality, including, but not limited to, prior hemorrhage or infarct >1 cm3, >3 lacunar infarcts, cerebral contusion, encephalomalacia, aneurysm, vascular malformation, subdural hematoma, hydrocephalus, space-occupying lesion (e.g. abscess or brain tumor such as meningioma). If a small incidental meningioma is observed, the medical monitor may be contacted to discuss eligibility..
2. Clinical or laboratory findings consistent with:
1. Other primary degenerative dementia, (dementia with Lewy bodies, fronto-temporal dementia, Huntington's disease, Creutzfeldt-Jakob Disease, Down syndrome, etc.).
2. Other neurodegenerative condition (Parkinson's disease, amyotrophic lateral sclerosis, etc.).
3. Seizure disorder.
4. Other infectious, metabolic or systemic diseases affecting the central nervous system (syphilis, present hypothyroidism, present vitamin B12 or folate deficiency, other laboratory values etc.).
3. A current DSM-V diagnosis of active major depression, schizophrenia or bipolar disorder. Subjects with depressive symptoms successfully managed by a stable dose of an antidepressant are allowed entry.
4. Clinically significant, advanced or unstable disease that may interfere with outcome evaluations.
Endpoints (8)
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
Amyloid biomarkers
2 endpointsAmyloid Beta 1-42/Amyloid Beta 1-40 (Aβ42/40) in the Cerebrospinal Fluid (CSF) Biomarkers
Time frame:Baseline to Day 182
concentration, descriptive
Amyloid Beta 1-42/Amyloid Beta 1-40 (Aβ42/40) in the Cerebrospinal Fluid (CSF) Biomarkers
Time frame:Baseline to Day 182
concentration, descriptive
Posted result
| Group | Value (mean), ratio | Standard deviation |
|---|---|---|
| Active Treatment- CT1812 100 mgn=51 Participants | 0.019 | 0.0766 |
| Active Treatment- CT1812 300 mgn=50 Participants | -0.024 | 0.0631 |
| Placebo Comparator - Placebon=49 Participants | -0.002 | 0.0594 |
Neurodegeneration biomarkers
2 endpointsChange From Baseline in the Cerebrospinal Fluid (CSF) Biomarkers
Time frame:Baseline to Day 182
Neurofilament light (NfL)
change from baseline, improvement
Change From Baseline in the Cerebrospinal Fluid (CSF) Biomarkers
Time frame:Baseline to Day 182
Neurofilament light (NfL)
change from baseline, improvement
Posted result
| Group | Value (mean), ng/L | Standard deviation |
|---|---|---|
| Active Treatment- CT1812 100 mgAlpha Synuclein Protein (ASYNP) (ng/L) - Concentration change in CSF from Baseline to Day 182n=17 Participants | 48.6 | 625.13 |
| Amyloid Beta 1-40 (Aβ40) (ng/L) -Concentration change in CSF from Baseline to Day 182n=23 Participants | -573.9 | 2228.80 |
| Amyloid Beta 1-42 (Aβ42) (ng/L) -Concentration change in CSF from Baseline to Day 182n=23 Participants | -13.5 | 105.66 |
| Glial Fibrillary Acidic Protein (GFAP) (ng/L) - Concentration change in CSF from Baseline to Day 182n=19 Participants | -81.9 | 457.85 |
| Neurofilament Light Chain Protein (NFLP) (ng/L) Concentration change in CSF from Baseline to Day 182n=24 Participants | 72.8 | 317.59 |
| Neurogranin (NRGR) (ng/L) - Concentration change in CSF from Baseline to Day 182n=24 Participants | 19.70 | 82.557 |
| Phosphorylated Tau Protein 181 (pTau181) (ng/L) Concentration change in CSF from Baseline to Day 182n=24 Participants | -0.74 | 37.227 |
| Synaptosomal-Associated Protein 25 (SNAP25) Concentration change in CSF from Baseline to Day 182n=24 Participants | -0.88 | 6.485 |
| Synaptotagmin (SYN) Concentration change in CSF from Baseline to Day 182n=24 Participants | 0.75 | 15.041 |
| Tau Protein (TPROT) (ng/L) Concentration change in CSF from Baseline to Day 182n=24 Participants | -8.4 | 204.92 |
| Active Treatment- CT1812 300 mgAlpha Synuclein Protein (ASYNP) (ng/L) - Concentration change in CSF from Baseline to Day 182n=10 Participants | 38.3 | 213.10 |
| Amyloid Beta 1-40 (Aβ40) (ng/L) -Concentration change in CSF from Baseline to Day 182n=18 Participants | -1076.7 | 1781.36 |
| Amyloid Beta 1-42 (Aβ42) (ng/L) -Concentration change in CSF from Baseline to Day 182n=18 Participants | -72.1 | 121.62 |
| Glial Fibrillary Acidic Protein (GFAP) (ng/L) - Concentration change in CSF from Baseline to Day 182n=11 Participants | -87.4 | 176.01 |
| Neurofilament Light Chain Protein (NFLP) (ng/L) Concentration change in CSF from Baseline to Day 182n=17 Participants | -55.5 | 262.24 |
| Neurogranin (NRGR) (ng/L) - Concentration change in CSF from Baseline to Day 182n=18 Participants | -22.77 | 68.348 |
| Phosphorylated Tau Protein 181 (pTau181) (ng/L) Concentration change in CSF from Baseline to Day 182n=18 Participants | -9.76 | 45.506 |
| Synaptosomal-Associated Protein 25 (SNAP25) Concentration change in CSF from Baseline to Day 182n=17 Participants | -1.64 | 4.767 |
| Synaptotagmin (SYN) Concentration change in CSF from Baseline to Day 182n=17 Participants | -19.44 | 98.693 |
| Tau Protein (TPROT) (ng/L) Concentration change in CSF from Baseline to Day 182n=18 Participants | -47.8 | 358.68 |
| Placebo Comparator - PlaceboAlpha Synuclein Protein (ASYNP) (ng/L) - Concentration change in CSF from Baseline to Day 182n=16 Participants | -831.2 | 3056.97 |
| Amyloid Beta 1-40 (Aβ40) (ng/L) -Concentration change in CSF from Baseline to Day 182n=24 Participants | -17.9 | 1633.79 |
| Amyloid Beta 1-42 (Aβ42) (ng/L) -Concentration change in CSF from Baseline to Day 182n=24 Participants | 3.1 | 90.90 |
| Glial Fibrillary Acidic Protein (GFAP) (ng/L) - Concentration change in CSF from Baseline to Day 182n=17 Participants | -69.1 | 321.21 |
| Neurofilament Light Chain Protein (NFLP) (ng/L) Concentration change in CSF from Baseline to Day 182n=24 Participants | 297.7 | 535.60 |
| Neurogranin (NRGR) (ng/L) - Concentration change in CSF from Baseline to Day 182n=24 Participants | -16.93 | 44.348 |
| Phosphorylated Tau Protein 181 (pTau181) (ng/L) Concentration change in CSF from Baseline to Day 182n=24 Participants | -4.03 | 13.185 |
| Synaptosomal-Associated Protein 25 (SNAP25) Concentration change in CSF from Baseline to Day 182n=24 Participants | -1.04 | 3.763 |
| Synaptotagmin (SYN) Concentration change in CSF from Baseline to Day 182n=24 Participants | 4.66 | 56.365 |
| Tau Protein (TPROT) (ng/L) Concentration change in CSF from Baseline to Day 182n=24 Participants | -9.4 | 80.67 |
Safety / tolerability / PK
4 endpointsNumber of Study Participants With at Least One Mild, Moderate, or Severe Treatment Emergent Adverse Events (TEAEs)
Time frame:Up to 210 Days
event count, event
Number of Study Participants With at Least One Treatment Emergent Adverse Events (TEAs) and Serious Adverse Events (SAEs).
Time frame:Up to 210 Days
event count, event
Number of Study Participants With at Least One Mild, Moderate, or Severe Treatment Emergent Adverse Events (TEAEs)
Time frame:Up to 210 Days
event count, event
Posted result
| Group | Value (count_of_participants), Participants | Reported bounds |
|---|---|---|
| Active Treatment- CT1812 100 mgAll TEAEsn=51 Participants | 36 | - |
| Mild TEAEsn=51 Participants | 19 | - |
| Moderate TEAEsn=51 Participants | 16 | - |
| Severe TEAEsn=51 Participants | 1 | - |
| Active Treatment- CT1812 300 mgAll TEAEsn=51 Participants | 42 | - |
| Mild TEAEsn=51 Participants | 22 | - |
| Moderate TEAEsn=51 Participants | 16 | - |
| Severe TEAEsn=51 Participants | 4 | - |
| Placebo Comparator - PlaceboAll TEAEsn=50 Participants | 39 | - |
| Mild TEAEsn=50 Participants | 22 | - |
| Moderate TEAEsn=50 Participants | 14 | - |
| Severe TEAEsn=50 Participants | 3 | - |
Number of Study Participants With at Least One Treatment Emergent Adverse Events (TEAs) and Serious Adverse Events (SAEs).
Time frame:Up to 210 Days
event count, event
Posted result
| Group | Value (count_of_participants), Participants | Reported bounds |
|---|---|---|
| Active Treatment- CT1812 100 mgParticipants with at least one TEAEn=51 Participants | 36 | - |
| Participants with at least one TEAE related to treatmentn=51 Participants | 11 | - |
| Participants with a TEAE leading to study drug discontinuationn=51 Participants | 0 | - |
| Participants with a TEAE leading to deathn=51 Participants | 0 | - |
| Participants with at least one SAEn=51 Participants | 2 | - |
| Participants with at least one SAE related to treatmentn=51 Participants | 0 | - |
| Active Treatment- CT1812 300 mgParticipants with at least one TEAEn=51 Participants | 42 | - |
| Participants with at least one TEAE related to treatmentn=51 Participants | 16 | - |
| Participants with a TEAE leading to study drug discontinuationn=51 Participants | 11 | - |
| Participants with a TEAE leading to deathn=51 Participants | 0 | - |
| Participants with at least one SAEn=51 Participants | 3 | - |
| Participants with at least one SAE related to treatmentn=51 Participants | 1 | - |
| Placebo Comparator - PlaceboParticipants with at least one TEAEn=50 Participants | 39 | - |
| Participants with at least one TEAE related to treatmentn=50 Participants | 7 | - |
| Participants with a TEAE leading to study drug discontinuationn=50 Participants | 3 | - |
| Participants with a TEAE leading to deathn=50 Participants | 1 | - |
| Participants with at least one SAEn=50 Participants | 5 | - |
| Participants with at least one SAE related to treatmentn=50 Participants | 0 | - |
Publications (4)
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
- PMID38914170via DERIVED
- PMID41943055via DERIVED
- PMID39166791via DERIVED
- PMID41930592via DERIVED
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.