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ACTIVE NOT RECRUITING Phase 2

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

NCT05267535 · View on ClinicalTrials.gov ↗

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

2 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05267535

The ClinicalTrials.gov registry entry for NCT05267535 describes a study currently listed as active not recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 225 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Neurim Pharmaceuticals, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Alzheimer's Disease appearing as the primary indexed condition, and to 2 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05267535 reports 20 study locations spanning 3 distinct geographic areas — top geographies include Florida, California, Colorado. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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: Alzheimer's Disease. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05267535?

The interventions under investigation include: Placebo (DRUG), Piromelatine 20 mg (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05267535?

This trial is sponsored by Neurim Pharmaceuticals, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

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