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Active Treatment- CT1812

Phase 1

Alzheimer Disease | Small molecule | Neurology |Cognition Therapeutics, Inc.|Last Updated: Sep 7, 2023

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment43

FDA Designations

No designations recorded

Clinical trial landscape

Active Treatment- CT1812 · 1 trial · 1 indication

Phase 1 1
NCT03493282Effect of CT1812 Treatment on Brain Synaptic DensityAlzheimer Disease
COMPLETED43 Analytics
PHASE1COMPLETED
Effect of CT1812 Treatment on Brain Synaptic Density
Alzheimer DiseaseUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of TEAEs, Related TEAEs, SAEs, and Related SAEs
Up to 12 months

Number of subjects reported with AEs and the number of AEs reported following administration of the IP summarized by treatment and grouped according to system organ class and preferred term, using descriptive statistics. Summaries of AEs were also presented by severity and by relationship to investigational product. In these summaries, subjects were counted only once per MedDRA term, for the AE of highest severity or least favorable relationship. Summaries were also presented of SAEs and of AEs leading to study withdrawal.

Secondary Endpoints

Change From Baseline in the Imaging of [11C] UCB-J PET Distribution Volume Ratio (DVR)
Day 169
Change From Baseline in the Imaging of [18F]FDG PET SUV Ratio (SUVR)
Day 169
Change From Baseline in Volumetric Magnetic Resonance Imaging (MRI)
Day 169
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
300 mgACTIVE_COMPARATORHigh Dose CT1812
100 mgACTIVE_COMPARATORLow Dose CT1812
PlaceboPLACEBO_COMPARATORMatching Placebo

Interventions

NameTypeDescription
Active Treatment- CT1812 100 mgDRUGCT1812
Active Treatment- CT1812 300 mgDRUGCT1812
PlaceboDRUGMatching Placebo
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Eligibility Criteria

Age Range50 Years to 85 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Participants may be included in the study only if they meet all of the following 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 ...

Countries:United States
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