Phase 2
Completed N=371
Safety and Efficacy of Piromelatine in Mild Alzheimer's Disease Patients (ReCOGNITION)
Source: ClinicalTrials.gov NCT02615002 ↗Enrolled (actual)
371
Serious AEs
2.5%
Results posted
Jul 2024
Primary outcomePrimary: Computerized Neuropsychological Test Battery (cNTB) Z-Scores - Change From Baseline — 0.0434; 0.1175; 0.0297; 0.0591 z-score
Summary
This study is a Phase 2, randomized, placebo-controlled, dose-ranging study of piromelatine (5, 20, and 50 mg daily for 6 months) versus placebo to determine an effective dose based on efficacy (cognitive performance), safety, and tolerability in patients with mild dementia due to Alzheimer's Disease (AD).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Computerized Neuropsychological Test Battery (cNTB) Z-Scores - Change From Baseline |
0.0434; 0.1175; 0.0297; 0.0591 | — |
| SECONDARY Change From Baseline in Global Impression of Change (CGIC) |
3.93; 3.95; 3.87; 3.89; 4.13; 3.94 | — |
| SECONDARY Alzheimer's Disease Cooperative Study/Activities of Daily Living Scale Adapted for MCI (Mild Cognitive Impairment) Patients (ADCS-MCI-ADL) |
40.7; 38.4; 39.2; 39.4; 40.4; 39.6 | — |
| SECONDARY Alzheimer's Disease Assessment Scale Cognitive Subscale (ADAS-cog14) |
26.1; 26.3; 26.4; 26.6; 25.1; 26.7 | — |
| SECONDARY Safety and Tolerability - Blood Pressure (mmHg) |
128.7; 130.8; 128.5; 132.3; 131.9; 132.4 | — |
| SECONDARY Safety and Tolerability - Heart Rate (Bpm) |
68.1; 68.7; 69.6; 67.2; 65.9; 67.0 | — |
| SECONDARY Safety and Tolerability - ECG Interval Results - QTcF (Msec) |
417.1; 416.4; 413.9; 416.5; 414.3; 421.2 | — |
| SECONDARY Safety and Tolerability - Hematology |
0.050; 0.070; 0.067; 0.063; 0.080; 0.050 | — |
| SECONDARY Safety and Tolerability - Blood Chemistry (mmol/L) |
5.89; 5.97; 5.51; 5.78; 5.86; 6.25 | — |
Eligibility Criteria
Inclusion Criteria
- Patient and caregiver are willing to take part in the entire study
- Signed informed consent from the patient and the caregiver
- Patient has a documented history either in medical records or from an informant of cognitive decline over at least 6 months
- Patient has mild probable AD as consistent with criteria established by the National Institute on Aging and Alzheimer's Association (NIA-AA).
- CT/MRI scan with finding consisting of probable AD obtained during the last 12 months before Screening
- Patient has an MMSE score of 21-26 (inclusive) at Screening
- Patient has a Clinical Dementia Rating Global Score (CDR-GS) of 0.5-1 (mild dementia) at Screening
- Patients receiving prescribed drugs for treatment of AD including acetyl cholinesterase inhibitors [eg, donepezil, galantamine, rivastigmine] should be on a stable dose for at least 3 months before Screening
- Patient has a negative drug screen (benzodiazepines or opiates) at Screening
- Female patients must have had last natural menstruation ≥ 24 months before Screening, OR being surgically sterile
- Male patients must agree to the use of effective contraception if the female partner is of childbearing potential, OR be surgically sterile
Exclusion Criteria
- Patient has an alternative cause for dementia other than AD as determined by CT or MRI scan
- Patient has evidence of any clinically significant neurodegenerative disease
- Patient has been diagnosed with the following Axis I disorders (DSM V criteria)
- Patient has a history of uncontrolled or untreated cardiovascular, endocrine, gastrointestinal, respiratory, or rheumatologic disorders within the past 5 years
- Patient has severe pain that is likely to interfere with sleep
- Continuous use of benzodiazepines or other sedative-hypnotics during the 2 weeks before Screening
- Use of any kind of melatonin/melatonin agonist during the 2 weeks before Screening
- Patient has known or suspected hypersensitivity to exogenous melatonin or melatonin receptor agonists
- Patients with an irregular lifestyle or life pattern (eg, shift workers, patients likely to be jet lagged).
Data sourced from ClinicalTrials.gov (NCT02615002). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.