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Small Molecule

CT1812 for Lewy Body Dementia (COG1201 Trial)

Verified Trial
Phase 2
Recruiting
Research Sponsored by Cognition Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Men or women 50-85 years of age (inclusive), meeting criteria for probable Dementia with Lewy Bodies (DLB)
MRI, or CT scan due to contraindication of MRI if approved by medical monitor) obtained during screening consistent with the clinical diagnosis of DLB and without findings of significant exclusionary abnormalities. An historical MRI (or CT scan), up to 1 year prior to screening, may be used if there is no history of intervening neurologic disease or clinical events (such as a stroke, head trauma etc.) and the subject is without clinical symptoms or signs suggestive of such intervening events
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 3 months, 6 months
Awards & highlights

COG1201 Trial Summary

This trial tests whether the study drug is better than placebo at improving thinking and memory in people with mild to moderate dementia with Lewy bodies.

Who is the study for?
This trial is for men and women aged 50-85 with mild to moderate Dementia with Lewy Bodies (DLB). Participants must have a certain score on a cognitive test and an MRI or CT scan that supports the DLB diagnosis without major brain abnormalities. People with other serious neurological diseases, psychiatric diagnoses like schizophrenia or bipolar disorder, unstable illnesses, or recent significant brain events cannot join.Check my eligibility
What is being tested?
The study tests the safety and effectiveness of CT1812 in treating DLB. It's a multi-center trial where participants are randomly assigned to receive either CT1812 or a placebo over six months, without knowing which one they're getting.See study design
What are the potential side effects?
While specific side effects of CT1812 aren't listed here, common ones may include gastrointestinal issues, headaches, dizziness, fatigue, allergic reactions or skin rashes. Side effects can vary from person to person.

COG1201 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 50-85 years old and likely have Dementia with Lewy Bodies.
Select...
My recent brain scans are consistent with DLB diagnosis and show no major issues.

COG1201 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 3 months, 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 3 months, 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Safety and Tolerability of CT1812
Secondary outcome measures
ADCS - Activities of Daily Living (ADCS-ADL)
ADCS-Clinical Global Impression of Change (CGIC)
Clinician Assessment of Fluctuation (CAF)
+5 more

COG1201 Trial Design

3Treatment groups
Active Control
Placebo Group
Group I: CT1812 300 mgActive Control1 Intervention
CT1812 300 mg
Group II: CT1812 100 mgActive Control1 Intervention
CT1812 100 mg
Group III: PlaceboPlacebo Group1 Intervention
Placebo

Find a Location

Who is running the clinical trial?

National Institute on Aging (NIA)NIH
1,660 Previous Clinical Trials
28,004,739 Total Patients Enrolled
263 Trials studying Dementia
23,622,892 Patients Enrolled for Dementia
Cognition TherapeuticsLead Sponsor
11 Previous Clinical Trials
1,384 Total Patients Enrolled
Anthony Caggiano, MDStudy DirectorCognition Therapeutics Inc.
4 Previous Clinical Trials
961 Total Patients Enrolled

Media Library

CT1812 (Small Molecule) Clinical Trial Eligibility Overview. Trial Name: NCT05225415 — Phase 2
Dementia Research Study Groups: CT1812 300 mg, CT1812 100 mg, Placebo
Dementia Clinical Trial 2023: CT1812 Highlights & Side Effects. Trial Name: NCT05225415 — Phase 2
CT1812 (Small Molecule) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05225415 — Phase 2
Dementia Patient Testimony for trial: Trial Name: NCT05225415 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any qualifications for participating in this clinical experiment?

"This clinical trial aims to enroll 120 patients with lewy body disease, aged 50 and above. Those interested should have a caregiver/study partner that can assist them throughout the study, men willing to use contraception methods or women of non-childbearing age, be able to undergo lumbar puncture tests at specified times during the trial period, possess 8 years of formal education or more, reside in their own home or an assisted living facility,, demonstrate general healthiness as well as adequate mobility vision and hearing for compliance with testing procedures., understand all aspects of the study before providing written consent., and finally meet criteria for probable Dementia"

Answered by AI

What is the overall scope of this investigation?

"Currently, 32 medical centres are participating in this study. These sites can be found in Chapel Hill, Winter Park and Lexington as well as 29 other cities. If you decide to enrol in the trial, it is recommended that you choose a location near your residence to reduce travel expenditure."

Answered by AI

Does this experiment offer enrollment to individuals who are over five decades of age?

"Qualified applicants for this clinical trial must be aged between 50 to 85. For those below 18, there are 25 seperate trials and 399 alternate studies available to people over 65 years old."

Answered by AI

What is the total participant count for this clinical research endeavor?

"The trial sponsor, Cognition Therapeutics, will be initiating the study from two different sites: UNC Department of Neurology in Chapel Hill, North carolina and Charter Research in Winter Park, Florida. To commence research operations a total of 120 suitable participants must be enrolled."

Answered by AI

What potential risks have been associated with 100 mg of CT1812?

"Our experts at Power have given CT1812 100 mg a rating of 2, indicating that there is some evidence on its safety but none regarding its efficacy."

Answered by AI

Are there any opportunities for individuals to be enrolled in this experimental protocol?

"Affirmative. Clinicaltrials.gov displays that the medical study, which was initially posted on June 22nd 2022, is presently looking for participants. A total of 120 individuals are needed to be enrolled from 32 separate clinical sites."

Answered by AI

Who else is applying?

What state do they live in?
Colorado
What site did they apply to?
CenExel Rocky Mountain Clinical Research, LLC
Pacific Neuroscience Institute
University of Colorado
Other
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
0
1

What questions have other patients asked about this trial?

what does it entail?
PatientReceived no prior treatments

Why did patients apply to this trial?

I’m frustrated in feeling I’m not able to get the help I need.
PatientReceived no prior treatments
~0 spots leftby Apr 2024