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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: Active Phase 2 study of Alzheimers Disease, sponsored by Neurim Pharmaceuticals.
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 3,925-participant average among 147 other Alzheimers Disease trials with a reported enrollment target (94% lower). The trial reports 20 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The ADAS was designed to measure the severity of the most important symptoms of AD. . It consists of 11 tasks measuring the disturbances of memory, language, praxis, attention, and other cognitive abilities that are often referred to as the core symptoms of AD. The test comprises 11 items summed to a total score ranging from 0 to 70, with lower scores indicating less severe impairment. A negative change indicates an improvement from baseline. The addition of delayed recall, number cancelation, a
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
| Field | Value |
|---|---|
| Enrollment Target | 225 participants |
| Start Date | 2022-05-12 |
| Est. Completion | 2025-06 |
| Phase | Phase 2 |
What the registry record for NCT05267535 still lists
NCT05267535 is an interventional study that assigns participants to a tested intervention. The registered 225 participants enrollment target is mid-sized for trials with a published cap, below the 3,925-participant average among 147 other Alzheimers Disease trials with a reported enrollment target (94% lower).
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 names 20 study sites across 3 states, led by 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.
Learn More About Clinical Trials
Similar trials for Alzheimers Disease
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05267535's enrollment target sits among peer trials
225 54th of 147 higher than 94 of 147 other Alzheimers Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Alzheimers Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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