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CMS121 for Alzheimer's Disease (CMS121 Trial)

Phase 1
Waitlist Available
Led By Scott Rasmussen, MD
Research Sponsored by Virogenics, Inc.
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 from baseline on day 1 and for 24hr post day 1 dose for sad cohorts; from baseline on day 1 and for 24hr post-dose after day 7 dose for mad cohorts.

Summary

This trial tests a new drug called CMS121 in healthy young and elderly people to see if it is safe and how it behaves in the body. Researchers will give different doses to understand its effects and any side effects. CMS121 is a drug candidate for Alzheimer's disease that has shown potential to prevent age-associated diseases in both brain and kidney.

Eligible Conditions
  • Alzheimer's Disease

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline on day 1 and for 24hr post day 1 dose for sad cohorts; from baseline on day 1 and for 24hr post-dose after day 7 dose for mad cohorts.
This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline on day 1 and for 24hr post day 1 dose for sad cohorts; from baseline on day 1 and for 24hr post-dose after day 7 dose for mad cohorts. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Therapeutic procedure
Secondary study objectives
Safety: Effect on electrocardiographic parameters

Trial Design

7Treatment groups
Experimental Treatment
Placebo Group
Group I: Single ascending dose - CMS121Experimental Treatment1 Intervention
Subjects will receive a single oral dose of CMS121 under fed conditions.
Group II: Multiple ascending dose - Elderly cohort - CMS121Experimental Treatment1 Intervention
Subjects will receive multiple oral doses of CMS121 once daily (QD) for 7 days under fed conditions.
Group III: Multiple ascending dose - CMS121Experimental Treatment1 Intervention
Subjects will receive multiple oral doses of CMS121 once daily (QD) for 7 days under fed conditions.
Group IV: Food Effect - CMS121Experimental Treatment1 Intervention
On Day 1 of each of 2 treatment periods, a single oral dose of CMS121 will be administered following either a standard high fat/high calorie meal (Treatment A) or an overnight fast (Treatment B), as per each subject's assigned randomization sequence (AB or BA). There will be a washout of at least 7 days between doses.
Group V: Single ascending dose - placeboPlacebo Group1 Intervention
Subjects will receive a single oral dose of placebo under fed conditions.
Group VI: Multiple ascending dose - Elderly cohort - placeboPlacebo Group1 Intervention
Subjects will receive multiple oral doses of placebo once daily (QD) for 7 days under fed conditions.
Group VII: Multiple ascending dose - placeboPlacebo Group1 Intervention
Subjects will receive multiple oral doses of placebo once daily (QD) for 7 days under fed conditions.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
CMS121
2022
Completed Phase 1
~100

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Virogenics, Inc.Lead Sponsor
National Institute on Aging (NIA)NIH
1,789 Previous Clinical Trials
28,188,233 Total Patients Enrolled
CelerionIndustry Sponsor
84 Previous Clinical Trials
7,831 Total Patients Enrolled
~28 spots leftby Dec 2025