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NCT05531656 · ClinicalTrials.gov registry record · Phase 2
A Study to Evaluate the Safety and Efficacy of CT1812 in Early Alzheimer's Disease
A Phase 2 study of Early Alzheimer's Disease, sponsored by Cognition Therapeutics.
- Active
- Registry status
- Phase 2
- Development phase
- 540
- Enrollment target
- 20
- Study locations
NCT05531656: Active Phase 2 study of Early Alzheimer's Disease, sponsored by Cognition Therapeutics.
NCT05531656 is a Phase 2 study of Early Alzheimer's Disease that is active but no longer recruiting, run by Cognition Therapeutics. The registered enrollment target is 540 participants, below the 1,025-participant average among 7 other Early Alzheimer's Disease trials with a reported enrollment target (47% lower). The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05531656, a Phase 2 study of Early Alzheimer's Disease, is active but no longer recruiting, sponsored by Cognition Therapeutics.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 540 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a multicenter randomized, double-blind, placebo-controlled Phase 2 study designed to evaluate the efficacy, safety, and tolerability of two doses of CT1812 compared to placebo in participants diagnosed with early Alzheimer's disease.
Primary Outcome
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
Conditions Studied
Interventions
- DRUG Placebo
- DRUG CT1812
Study Locations (20)
Florida
- Brain Matters Research - Delray Beach
- Neuropsychiatric Research Center of Southwest Florida - Fort Myers
- Mayo Clinic,Jacksonville - Jacksonville
- JEM Research Institute - Lake Worth
- K2 Medical Research, LLC - Maitland
- Advanced Clinical Research Network, Corp - Miami
- Charter Research - Orlando
- Headlands Research Orlando - Orlando
- Brain Matters Research Stuart - Stuart
- University of South Florida - Tampa
- Conquest Research, LLC - Winter Park
California
- University of California - Irvine
- Stanford University - Palo Alto
- Sutter Institute for Medical Research - Sacramento
Arizona
- Banner Alzheimer's Institute - Phoenix
- Banner Sun Health Research Institute - Sun City
District of Columbia
- Georgetown University - Washington D.C.
- Howard University - Washington D.C.
Alabama
- University of Alabama at Birmingham - Birmingham
Connecticut
- Yale University - New Haven
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 540 participants |
| Start Date | 2023-06-28 |
| Est. Completion | 2027-04 |
| Phase | Phase 2 |
What the registry record for NCT05531656 still lists
NCT05531656 is an interventional study that assigns participants to a tested intervention. The registered 540 participants enrollment target is mid-sized for trials with a published cap, below the 1,025-participant average among 7 other Early Alzheimer's Disease trials with a reported enrollment target (47% lower).
The record links to 1 condition, with Early Alzheimer's Disease appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT05531656 names 20 study sites across 6 states, led by Florida, California, Arizona.
Frequently Asked Questions
What is clinical trial NCT05531656 about?
NCT05531656 is a clinical study titled "A Study to Evaluate the Safety and Efficacy of CT1812 in Early Alzheimer's Disease". This is a multicenter randomized, double-blind, placebo-controlled Phase 2 study designed to evaluate the efficacy, safety, and tolerability of two doses of CT1812 compared to placebo in participants diagnosed with early Alzheimer's disease.
What is the current status of trial NCT05531656?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 540 participants. The study started on 2023-06-28. Estimated completion is 2027-04.
What conditions does trial NCT05531656 study?
This clinical trial studies the following conditions: Early Alzheimer's Disease.
What interventions are being tested in trial NCT05531656?
The interventions under investigation include: Placebo (DRUG), CT1812 (DRUG).
Who is sponsoring clinical trial NCT05531656?
This trial is sponsored by Cognition Therapeutics, which has 9 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05531656 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Connecticut, District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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