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CT1812 for Early Alzheimer's Disease
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 18 months
Summary
This trial will test whether a new drug can help treat early Alzheimer's.
Who is the study for?
This trial is for people aged 50-85 with early Alzheimer's, confirmed by brain scans or biomarkers. They should have mild cognitive impairment (MMSE score of 20-30) and no major psychiatric disorders, significant brain abnormalities, other neurodegenerative diseases, or active hepatitis infections.
What is being tested?
The study tests the safety and effectiveness of CT1812 versus a placebo in those with early Alzheimer's. Participants are randomly assigned to receive either CT1812 or a placebo without knowing which one they're getting.
What are the potential side effects?
While specific side effects aren't listed here, common ones for Alzheimer's treatments may include headache, nausea, diarrhea, fatigue and falls. The trial will monitor participants closely for any adverse reactions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 18 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~18 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change from baseline in the Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) scale.
Secondary study objectives
Alzheimer's Disease Assessment Scale-Cognition (ADAS-Cog 13)
Alzheimer's Disease Cooperative Study - Activities of Daily Living Scale (ADCS - ADL) in people with Mild Cognitive Impairment (MCI) - ADCS-ADL-MCI.
Cerebrospinal fluid (CSF) concentrations of beta-amyloid (Aβ) 40 and 42, tau, phospho-tau (ptau), neurofilament light (NfL), neurogranin, and synaptotagmin.
+2 moreTrial Design
3Treatment groups
Active Control
Placebo Group
Group I: CT1812 200 mgActive Control1 Intervention
CT1812 at a dose of 300mg, n=180 group
Group II: CT1812 100 mgActive Control1 Intervention
CT1812 at a dose of 100 n=180 group
Group III: PlaceboPlacebo Group1 Intervention
Placebo, n=180 group
Find a Location
Who is running the clinical trial?
Alzheimer's Clinical Trials ConsortiumOTHER
4 Previous Clinical Trials
2,220 Total Patients Enrolled
Cognition TherapeuticsLead Sponsor
11 Previous Clinical Trials
749 Total Patients Enrolled
National Institute on Aging (NIA)NIH
1,802 Previous Clinical Trials
28,193,441 Total Patients Enrolled
Anthony Caggiano, MDStudy DirectorCognition Therapeutics
4 Previous Clinical Trials
326 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with early-stage Alzheimer's disease.I am between 50 and 85 years old.I have symptoms or test results that suggest a condition like Parkinson's or ALS.I have been diagnosed with major depression, schizophrenia, or bipolar disorder.I have been diagnosed with a type of dementia other than Alzheimer's.I have or had hepatitis B or C.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: CT1812 200 mg
- Group 3: CT1812 100 mg
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.