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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)
Be older than 18 years old
Must not have
Other primary degenerative dementia (fronto-temporal dementia, Huntington's disease, Creutzfeldt-Jakob Disease, Down syndrome, etc.)
Other neurodegenerative condition (amyotrophic lateral sclerosis, etc.)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 3 months, 6 months
Awards & highlights

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 50-85 years old and likely have Dementia with Lewy Bodies.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a diagnosis of a specific type of dementia, not Alzheimer's.
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I have a condition like ALS affecting my nervous system.
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I have a seizure disorder.
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I do not have a major psychiatric condition like schizophrenia, bipolar disorder, or severe depression.

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

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
1,704 Previous Clinical Trials
28,033,137 Total Patients Enrolled
278 Trials studying Dementia
23,628,743 Patients Enrolled for Dementia
Cognition TherapeuticsLead Sponsor
11 Previous Clinical Trials
1,159 Total Patients Enrolled
Anthony Caggiano, MDStudy DirectorCognition Therapeutics Inc.
4 Previous Clinical Trials
736 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
~38 spots leftby Jul 2025