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Piromelatine 20 mg in Participants With Mild Dementia Due to Alzheimer's Disease

NCT05267535 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 225

Last updated 2024-06-21

No results posted yet for this study

Summary

Randomized efficacy and safety study of piromelatine 20 mg versus placebo in participants with mild dementia due to Alzheimer's disease (AD) who are 2:107,510,000-107,540,000 polymorphism non-carriers with the primary objective to compare the effect of piromelatine to that of placebo on the AD Assessment Scale cognitive subscale (ADAS-cog14) at Week 26 of double-blind treatment.

Conditions

Interventions

DRUG

Piromelatine 20 mg

Tablets

DRUG

Placebo

Tablets

Sponsors & Collaborators

  • Syneos Health

    collaborator OTHER

  • Neurim Pharmaceuticals Ltd.

    lead INDUSTRY

Principal Investigators

  • Lon Schneider, MD · Keck School of Medicine of USC, Los Angeles, CA

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-12
Primary Completion
2025-06-30
Completion
2025-06-30
FDA Drug
Yes

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05267535 on ClinicalTrials.gov