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CT1812

Phase 2

Early Alzheimer's Disease | Small molecule | Neurology |Cognition Therapeutics, Inc.|Last Updated: Sep 22, 2025

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment540
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05531656A Study to Evaluate the Safety and Efficacy of CT1812 in Early Alzheimer's DiseasePHASE2 ACTIVE NOT_RECRUITING 540Jun 28, 2023Apr 1, 2027Sep 22, 202550 United States
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Study Endpoints
Primary Endpoints
Change from baseline in the Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) scale.
18 months

The Clinical Dementia Rating (CDR) is a clinical scale that describes 5 levels of impairment in performance on each of 6 categories of function including memory, orientation, judgment and problem solving, community affairs, home and hobbies, and personal care. The ratings of degree of impairment obtained on each of the 6 categories of function are synthesized into 1 global rating of dementia as absent, questionable, mild, moderate, or severe (global CDR scores of 0, 0.5, 1, 2, or 3, respectively). The score is based on interviews with the participant and study partner, using a structured interview. A sum of boxes score (CDR-SB) provides an additional measure of change where each category has a maximum possible score of 3 points and the total score is a sum of the category scores giving a total possible score of 0 to 18 with higher scores indicating more impairment.

Secondary Endpoints
Alzheimer's Disease Assessment Scale-Cognition (ADAS-Cog 13)
18 months
Alzheimer's Disease Cooperative Study - Activities of Daily Living Scale (ADCS - ADL) in people with Mild Cognitive Impairment (MCI) - ADCS-ADL-MCI.
18 months
Cerebrospinal fluid (CSF) concentrations of beta-amyloid (Aβ) 40 and 42, tau, phospho-tau (ptau), neurofilament light (NfL), neurogranin, and synaptotagmin.
18 months
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
CT1812 100 mgACTIVE_COMPARATORCT1812 at a dose of 100 n=180 group
CT1812 200 mgACTIVE_COMPARATORCT1812 at a dose of 300mg, n=180 group
PlaceboPLACEBO_COMPARATORPlacebo, n=180 group
Interventions
NameTypeDescription
CT1812DRUGStudy Drug
PlaceboDRUGNon-active study drug
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Eligibility Criteria
Age Range50 Years — 85 Years
SexALL
Healthy VolunteersNo
Study Sites50

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 ...

Countries:United States
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT05531656primaryCompletionDate: changed
LOWMay 24, 2026NCT05531656studyFirstPostDate: changed