Safety and Efficacy of Piromelatine in Mild Alzheimer's Disease Patients (ReCOGNITION)
Recruiting in Palo Alto (17 mi)
+55 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Waitlist Available
Sponsor: Neurim Pharmaceuticals Ltd.
Prior Safety Data
Trial Summary
What is the purpose of this trial?
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).
Research Team
LS
Lon Schneider, MD
Principal Investigator
Keck School of Medicine of USC, Los Angeles, CA
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 clearly documented history either in medical records or from an informant of cognitive decline over at least 6 months
See 7 more
Treatment Details
Interventions
- Piromelatine (Melatonin Receptor Agonist)
- Placebo (Other)
Participant Groups
4Treatment groups
Experimental Treatment
Placebo Group
Group I: Piromelatine 50 mgExperimental Treatment1 Intervention
2 weeks of Placebo (run-in), followed by 26 weeks of 50 mg tablets once daily.
Group II: Piromelatine 5 mgExperimental Treatment1 Intervention
2 weeks of Placebo (run-in), followed by 26 weeks of 5 mg tablets once daily.
Group III: Piromelatine 20 mgExperimental Treatment1 Intervention
2 weeks of Placebo (run-in), followed by 26 weeks of 20 mg tablets once daily.
Group IV: PlaceboPlacebo Group1 Intervention
2 weeks of Placebo (run-in), followed by 26 weeks of Placebo tablets once daily.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
The Roskamp Institute, IncSarasota, FL
Olympian Clinical ResearchTampa, FL
Rowe NeurologyLenexa, KS
SPRI Clinical Trials, LLCBrooklyn, NY
More Trial Locations
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Who Is Running the Clinical Trial?
Neurim Pharmaceuticals Ltd.
Lead Sponsor
Trials
17
Patients Recruited
2,300+