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Active not recruitingPhase 2

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.

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 dementiaMMSE 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

Org study IDCOG0203
NCT IDNCT05531656
NihR01AG065248

Timeline

Milestones

Study first posted2022-09-08actual
Study start2023-06-28actual
Last update posted2025-09-22actual
Primary completion2027-04estimated (month precision)
Study completion2027-04estimated (month precision)

Assets

Drug assets

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age50 Years
Maximum age85 Years
SexAll
Healthy volunteersNot accepted

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
Function / daily living
1
Amyloid biomarkers
1
Tau biomarkers
1
Neuroimaging
1

Global cognition

2 endpoints
Primary/protocol endpoint

Change 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

Secondary/protocol endpoint

Alzheimer's Disease Assessment Scale-Cognition (ADAS-Cog 13)

Time frame:18 months

ADAS-Cog

change from baseline, improvement

Function / daily living

1 endpoint
Secondary/protocol endpoint

Alzheimer'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 endpoint
Secondary/protocol endpoint

Cerebrospinal 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 endpoint
Secondary/protocol endpoint

Plasma measures of Aβ fragments, ptau, and Neurofilament light (NfL)

Time frame:18 months

Neurofilament light (NfL)

change from baseline, improvement

Neuroimaging

1 endpoint
Secondary/protocol endpoint

Volumetric Magnetic Resonance Imaging (MRI) including hippocampal and whole brain volume change

Time frame:18 months

change from baseline, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 21, 2026
Endpoint classificationDelfa ADRD endpoint taxonomy
Results tableno registry results posted yet

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.