Piromelatine for Alzheimer's Disease

Recruiting in Palo Alto (17 mi)

+36 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2 & 3

Waitlist Available

Sponsor: Neurim Pharmaceuticals Ltd.

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial tests piromelatine, a pill taken before bed, in people with mild Alzheimer's who lack a specific genetic variation. The goal is to see if it can improve brain function and slow down dementia progression.

Research Team

Lon Schneider, MD

Principal Investigator

Keck School of Medicine of USC, Los Angeles, CA

Eligibility Criteria

This trial is for adults aged 60-85 with mild dementia due to Alzheimer's, living at home or in assisted living, who can attend all visits and have a reliable study partner. They must be stable on current AD medications if used, not carriers of specific genetic polymorphisms, able to spend time in daylight daily, and agree to contraception if applicable. Exclusions include severe other diseases or conditions that could interfere with the study.

Inclusion Criteria

My mental abilities have been getting worse over the last year.

I have been diagnosed with mild dementia.

I am a woman who has not had a period in at least 2 years or I am surgically sterile.

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Exclusion Criteria

You must be willing to limit alcohol intake, avoid caffeine overconsumption, and maintain a regular lifestyle during the study. You must also not have a history of suicidal behavior or present a serious risk of suicide.

I chose not to have genetic testing for specific DNA changes and APOE4.

My dementia is not caused by Alzheimer's disease.

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Treatment Details

Interventions

Piromelatine 20 mg (Melatonin Receptor Agonist)
Placebo (Drug)

Trial OverviewThe trial tests Piromelatine 20 mg against a placebo in participants with mild Alzheimer's-related dementia. It aims to see how well Piromelatine works compared to a placebo by measuring cognitive function after 26 weeks using the AD Assessment Scale cognitive subscale (ADAS-cog14). Participants are randomly assigned either the drug or placebo.

Participant Groups

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Piromelatine 20 mgExperimental Treatment1 Intervention

Piromelatine 20 mg tablets once daily taken before going to bed, preferably between 2100h and 2300h, and after food consumption.

Group II: PlaceboPlacebo Group1 Intervention

Matched placebo tablets, with identical features to the piromelatine tablets, will be used as control treatment