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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
Awards & highlights

Study 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.Check my eligibility
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.See study design
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 weeks
Treatment ~ Varies
Follow Up ~18 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 18 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
Change from baseline in the Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) scale.
Secondary outcome measures
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 more

Trial 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
3,800 Total Patients Enrolled
Cognition TherapeuticsLead Sponsor
11 Previous Clinical Trials
964 Total Patients Enrolled
National Institute on Aging (NIA)NIH
1,675 Previous Clinical Trials
28,020,345 Total Patients Enrolled

Media Library

CT1812 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05531656 — Phase 2
Alzheimer's Disease Research Study Groups: Placebo, CT1812 200 mg, CT1812 100 mg
Alzheimer's Disease Clinical Trial 2023: CT1812 Highlights & Side Effects. Trial Name: NCT05531656 — Phase 2
CT1812 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05531656 — Phase 2

Frequently Asked Questions

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

Are senior citizens eligible to participate in this experimental undertaking?

"According to the outlined requirements, participants must be between 50 and 85 years of age in order to qualify for this trial."

Answered by AI

To what extent is CT1812 100 mg hazardous for human consumption?

"Due to the lack of efficacy data, we rate CT1812 100 mg as a 2 on our safety scale. Although there is some evidence suggesting it is safe, Phase 2 trials are not sufficient for determining effectiveness."

Answered by AI

Is enrollment still ongoing for this research study?

"Affirmative. Clinicaltrials.gov shows that this medical research, which was initialised on June 28th 2023, is still recruiting patients for its trials. 540 contributors are desired from a single centre."

Answered by AI

How many participants are currently being considered for inclusion in this clinical trial?

"Correct. According to the information published on clinicaltrials.gov, this medical trial is still recruiting participants since it was first posted on June 28th 2023 and recently updated on July 19th 2023. 540 people will be admitted from just 1 location."

Answered by AI

Who meets the criteria to participate in this scientific research?

"This study seeks to enroll 540 individuals aged 50-85 diagnosed with Alzheimer's disease. To qualify, participants must have an MMSE score between 20 and 30 (inclusive), evidence of AD as indicated by amyloid PET scan or CSF biomarkers, MRI scan results that correspond to the diagnosis of AD, documented consent for HIPAA authorization if applicable, non-childbearing potential in female biological sex persons unless they are postmenopausal or sterilized surgically; male participants who are sexually active should agree to use condoms during trial and 3 months afterwards unless their partner is using another form of birth control; be able to swallow CT18"

Answered by AI

Who else is applying?

What site did they apply to?
Butler Hospital
Georgetown University
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria

Why did patients apply to this trial?

Looking for a antibody treatment.
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
A Study to Evaluate the Safety and Efficacy of CT1812 in Early Alzheimer's Disease
2023. "A Study to Evaluate the Safety and Efficacy of CT1812 in Early Alzheimer's Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05531656.
All > Alzheimers Disease Boston
~360 spots leftby Apr 2027
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