Trial · NCT05267535
Piromelatine 20 mg in Participants With Mild Dementia Due to Alzheimer's Disease
NCT05267535, Phase 2, Phase 3, Terminated, Neurim Pharmaceuticals Ltd.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Piromelatine 20 mg in Participants With Mild Dementia Due to Alzheimer's Disease. Trials, record NCT05267535. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05267535
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Piromelatine 20 mg in Participants With Mild Dementia Due to Alzheimer's Disease
- NCT number
- NCT05267535
- Status
- Terminated
- Phases
- Phase 2, Phase 3
- Enrollment
- 216 participants, actual
- Lead sponsor
- Neurim Pharmaceuticals Ltd.
- Conditions
- Alzheimer's Disease
- Interventions
- Piromelatine 20 mg, Placebo
- First posted
- 2022-03-04
- Last updated
- 2026-09-09
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Alzheimer's Disease Assessment Scale Cognitive Subscale (ADAS-cog 14) | 26 weeks | 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, and maze tasks - and thus turning ADAS cog into a 12 , 13 , and 14 item scale respectively - has increased the ability to detect changes in patients in the early stages of the disease . |
| Secondary | Alzheimer's Disease Cooperative Study - Instrumental Activities of Daily Living (ADCS-iADL) | 26 weeks | The scale typically consists of 23 items. Each item is scored based on the level of independence, with higher scores reflecting better functioning. Total Score Range is 0 to 78. High scores indicate higher functioning and greater independence, while low scores indicate more severe impairment and greater dependence on caregivers. |
| Secondary | ADCS-Clinical Global Impression of Change (CGIC) | 26 weeks | The ADCS CGIC is a systematic method for assessing clinically significant change in a clinical trial as viewed by an independent skilled and experienced clinician. The ADCS CGIC focuses on clinicians' observations of change in the patient's cognitive, functional, and behavioral performance since the beginning of a trial.The ADCS CGIC requires the assessor to consider a number of cognitive, functional, and behavioral areas prior to providing an overall "global" assessment of clinical change (Schneider, Olin et al. 1997, Schneider, Clark et al. 2006). The ADCS CGIC assessor must be blinded to all other data for the patient after Visit 2. |
| Secondary | Mini-Mental State Examination (MMSE) | 26 weeks | The MMSE is a brief assessment instrument used to assess cognitive function in elderly patients. The MMSE can be used to screen for cognitive impairment and as a measurement of cognition over time and with pharmacologic treatment. The instrument is divided into 2 sections. The first section measures orientation, memory, and attention: the maximum score is 21. The second section tests the ability of the patient to name objects, follow verbal and written commands, write a sentence, and copy figures: the maximum score is 9. The scoring range for the MMSE is 0 30. A positive change indicates an improvement from baseline |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 40375477 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05267535
GET https://conductscience.org/api/trials/v1/NCT05267535/registered