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A Study to Evaluate the Safety and Efficacy of CT1812 in Early Alzheimer's Disease
Synaptic Therapy Alzheimer's Research Trial (START): A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Trial to Evaluate the Safety and Efficacy of CT1812 in Early Alzheimer's Disease Over 18 Months.
Lead sponsor
Asset
CT1812
Listed sites
50
Recruiting sites
-
Enrollment
540
estimated
Study population
Alzheimer’s disease
Key I/E criteria
•MCI due to AD / mild AD dementia•MMSE 20-30
Primary endpoint
•Clinical Dementia Rating-Sum of Boxes (CDR-SB)
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. Ages 50-85 years.
2. Diagnosis of either MCI due to AD or mild AD dementia.
3. MMSE 20-30 (inclusive).
4. Amyloid PET scan of the brain or CSF biomarkers consistent with AD.
5. Neuroimaging (MRI) obtained during screening consistent with the clinical diagnosis of Alzheimer's disease, as based on central read
Exclusion criteria
1. Screening MRI of the brain indicative of significant abnormality.
2. Clinically significant abnormalities in screening laboratory tests.
3. 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. Other infectious, metabolic or systemic diseases affecting the central nervous system (syphilis, present hypothyroidism, present vitamin B12, other laboratory values etc.)
4. A participant known to be actively infected with hepatitis B or hepatitis C at screening. History of acute/chronic hepatitis B or C and/or carriers of hepatitis B (seropositive for hepatitis B surface antigen [HbsAg] or anti-hepatitis C [HCV] antibody). Participants who have evidence of resolved hepatitis infection (e.g., HCV RNA negative) may be considered following discussion with the Medical Monitor.
5. A current DSM-V diagnosis of active major depression or GDS > 6, schizophrenia, or bipolar disorder.
Endpoints (6)
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 endpointsChange from baseline in the Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) scale.
Time frame:18 months
Clinical Dementia Rating-Sum of Boxes (CDR-SB)
change from baseline, improvement
Alzheimer's Disease Assessment Scale-Cognition (ADAS-Cog 13)
Time frame:18 months
ADAS-Cog
change from baseline, improvement
Function / daily living
1 endpointAlzheimer's Disease Cooperative Study - Activities of Daily Living Scale (ADCS - ADL) in people with Mild Cognitive Impairment (MCI) - ADCS-ADL-MCI.
Time frame:18 months
ADCS-Activities of Daily Living (ADCS-ADL)
change from baseline, improvement
Amyloid biomarkers
1 endpointCerebrospinal fluid (CSF) concentrations of beta-amyloid (Aβ) 40 and 42, tau, phospho-tau (ptau), neurofilament light (NfL), neurogranin, and synaptotagmin.
Time frame:18 months
Neurofilament light (NfL)
change from baseline, improvement
Tau biomarkers
1 endpointPlasma measures of Aβ fragments, ptau, and Neurofilament light (NfL)
Time frame:18 months
Neurofilament light (NfL)
change from baseline, improvement
Neuroimaging
1 endpointVolumetric Magnetic Resonance Imaging (MRI) including hippocampal and whole brain volume change
Time frame:18 months
change from baseline, improvement
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.