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NCT05267535 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of Alzheimers Disease, sponsored by Neurim Pharmaceuticals.

Active
Registry status
Phase 2
Development phase
225
Enrollment target
20
Study locations

NCT05267535 is a Phase 2 study of Alzheimers Disease that is active but no longer recruiting, run by Neurim Pharmaceuticals. The registered enrollment target is 225 participants, below the 4,060-participant average among 142 other Alzheimers Disease trials with a reported enrollment target (94% lower). The trial reports 20 study locations across 3 states.

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The verdict

NCT05267535, a Phase 2 study of Alzheimers Disease, is active but no longer recruiting, sponsored by Neurim Pharmaceuticals.

ACTIVE NOT RECRUITING
Registry status
Phase 2
Development phase
225 participants
Enrollment target
20
Study locations

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 Studied

Interventions

  • DRUG Placebo
  • DRUG Piromelatine 20 mg

Study Locations (20)

Florida

  • Linfritz Research Institute Inc. - Coral Gables
  • Finlay Medical Research Corp. - Greenacres City
  • Velocity Clinical Research, Inc - Hallandale
  • K2 Medical Research The Villages - Lady Lake
  • Verus Clinical research Corp - Miami
  • BioMed Research Institute, Inc. - Miami
  • CCM Clinical Research Group, LLC - Miami
  • Advance Medical Research Center - Miami
  • Allied Biomedical Research Institute (Clinical Trials) - Miami
  • Vitae Research Center LLC. - Miami
  • Stein Gerontological Institute, Inc. - Miami
  • Miami Dade Medical Research Institute - Miami
  • K2 Medical Research Winter Garden - Ocoee
  • Interspond, LLC, - Orlando

California

  • ATP Clinical Research - Costa Mesa
  • Collaborative Neuroscience Research, LLC - Long Beach
  • Asclepes Research Centers, P.C. Dba Alliance Research - Long Beach
  • Pacific Research Network, LLC - San Diego
  • RAA Apex Acquisition LLC DBA Syrentis Clinical Research - Santa Ana

Colorado

  • The Mile High Research Center - Denver

Trial Details

FieldValue
Enrollment Target 225 participants
Start Date 2022-05-12
Est. Completion 2025-06
Phase Phase 2

Sponsor

Neurim Pharmaceuticals

6 total trials

What the Registry Record Tells You About NCT05267535

The ClinicalTrials.gov registry entry for NCT05267535 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 225 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 4,060-participant average among 142 other Alzheimers Disease trials with a reported enrollment target (94% lower). The listed sponsor is Neurim Pharmaceuticals, which has 6 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Alzheimers Disease appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT05267535 reports 20 study locations spanning 3 distinct geographic areas - top geographies include Florida, California, Colorado.

Frequently Asked Questions

What is clinical trial NCT05267535 about?

NCT05267535 is a clinical study titled "Piromelatine 20 mg in Participants With Mild Dementia Due to Alzheimer's Disease". 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 Asses...

What is the current status of trial NCT05267535?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 225 participants. The study started on 2022-05-12. Estimated completion is 2025-06.

What conditions does trial NCT05267535 study?

This clinical trial studies the following conditions: Alzheimers Disease.

What interventions are being tested in trial NCT05267535?

The interventions under investigation include: Placebo (DRUG), Piromelatine 20 mg (DRUG).

Who is sponsoring clinical trial NCT05267535?

This trial is sponsored by Neurim Pharmaceuticals, which has 6 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05267535 being conducted?

This trial has 20 study locations across California, Colorado, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.