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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
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.
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.
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 belowSelect...
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:Select...
I have a diagnosis of a specific type of dementia, not Alzheimer's.
Select...
I have a condition like ALS affecting my nervous system.
Select...
I have a seizure disorder.
Select...
I do not have a major psychiatric condition like schizophrenia, bipolar disorder, or severe depression.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 3 months, 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 3 months, 6 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Safety and Tolerability of CT1812
Secondary study objectives
ADCS - Activities of Daily Living (ADCS-ADL)
ADCS-Clinical Global Impression of Change (CGIC)
Clinician Assessment of Fluctuation (CAF)
+5 moreTrial 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
1,788 Previous Clinical Trials
28,184,393 Total Patients Enrolled
292 Trials studying Dementia
23,634,359 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a diagnosis of a specific type of dementia, not Alzheimer's.I have a condition like ALS affecting my nervous system.I do not have infections or conditions like hypothyroidism affecting my brain.My recent brain scans are consistent with DLB diagnosis and show no major issues.My condition is stable and won't affect the trial's outcome.I do not have a major psychiatric condition like schizophrenia, bipolar disorder, or severe depression.I have a seizure disorder.I am between 50-85 years old and likely have Dementia with Lewy Bodies.I have no other brain conditions affecting my thinking skills besides DLB.
Research Study Groups:
This trial has the following groups:- Group 1: CT1812 300 mg
- Group 2: CT1812 100 mg
- Group 3: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Dementia Patient Testimony for trial: Trial Name: NCT05225415 — Phase 2
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