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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.

Awards & highlights

CMS121 Trial Summary

This trial is testing a new drug, CMS121, on healthy young and old adults. The trial will last a total of 36-43 days, and will involve taking either the drug or a placebo. The trial will involve multiple doses of the drug, given either with or without food.

CMS121 Trial Timeline

Screening ~ 3 weeks3 visits

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Therapeutic procedure

Secondary outcome measures

Pharmacokinetics (PK): Blood concentration levels of CMS121

Pharmacokinetics (PK): Urine concentration levels of CMS121

Safety: Effect on electrocardiographic parameters

CMS121 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

Do I qualify?Apply below to find out

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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

1,672 Previous Clinical Trials

28,018,564 Total Patients Enrolled

CelerionIndustry Sponsor

81 Previous Clinical Trials

7,715 Total Patients Enrolled

Frequently Asked Questions

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

How many individuals have consented to participate in this experiment?

"Affirmative, the information available on clinicaltrials.gov attests that this medical trial is actively looking for participants. It was initially posted on May 1st 2022 and last edited on August 18th 2022; they are currently recruiting 100 individuals from a single site."

Answered by AI

What are the criteria to qualify for this medical experiment?

"This clinical study is actively seeking 100 Alzheimer's disease patients aged between 19 and 85. Essential criteria for applicants include: cognitive ability to comprehend the written informed consent form; voluntarily signing of a valid, legal document expressing their agreement; commitment to comply with all aspects of this medical trial; continuous abstinence from nicotine products in the three months prior to screening; BMI falling within the 18-32 kg/m2 range at time of evaluation; laboratory test results being within normal parameters or deemed inconsequential by researchers; confirmation that HIV, HBV, HCV are absent through testing procedures during initial assessment phase; female participants submitting negative pregnancy tests both initially"

Answered by AI

Is this research initiative still open to participants?

"Affirmative. Clinicaltrials.gov provides evidence that this medical experiment, first posted on May 1st 2022, is currently in the recruitment phase. Approximately 100 individuals need to be sourced from a single clinic for enrollment into the study."

Answered by AI

Is the age eligibility for this trial limited to individuals below 55 years old?

"For this particular trial, only those between the ages of 19 and 85 are eligible for participation. However, there are 23 clinical trials designed for minors age 18 or younger and 536 options available to individuals over 65."

Answered by AI

What risks do people face when exposed to CMS121?

"Due to a lack of existing clinical data for CMS121, our team at Power has assigned it a safety score of 1. This is because this study is in its initial phase and there are limited research results verifying the efficacy or safety of the drug."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Safety, Tolerability and Pharmacokinetics of CMS121, a Drug Candidate for Alzheimer's Disease, in Healthy Subjects

2022. "Safety, Tolerability and Pharmacokinetics of CMS121, a Drug Candidate for Alzheimer's Disease, in Healthy Subjects". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05318040.