Study of the Safety and Clinical Effects of 2 Doses of EVP-6124 in Subjects With Alzheimer's Disease Who Complete Study EVP-6124-024 or EVP-6124-025
Recruiting in Palo Alto (17 mi)
+85 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Waitlist Available
Sponsor: FORUM Pharmaceuticals Inc
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
Trial Summary
What is the purpose of this trial?
This is a 26-week, randomized extension of the Phase 3 double-blind placebo-controlled studies, EVP-6124-024 and EVP-6124-025. In this extension study, subjects who complete study EVP-6124-024 or EVP-6124-025 and fulfill all entry criteria will be randomized to receive EVP-6124 for an additional 26 weeks.
Research Team
Eligibility Criteria
Inclusion Criteria
Male or female subjects of any race, aged ≥55 and ≤85 years at time of entry into study EVP-6124-024 or EVP-6124-025
Informed consent form (ICF) for this extension study signed by the subject or legally acceptable representative and an ICF signed by the support person/caregiver before initiation of any study-specific procedures
Successful completion (Day 182) of study EVP-6124-024 or EVP-6124-025
See 4 more
Treatment Details
Interventions
- EVP-6124 (Other)
Participant Groups
2Treatment groups
Experimental Treatment
Group I: EVP-6124, low doseExperimental Treatment1 Intervention
low dose, Tablet, Once Daily, Day 1 through Day 182
Group II: EVP-6124, high doseExperimental Treatment1 Intervention
high dose, Tablet, Once Daily, Day 1 through Day 182
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
NCT02004392Delray Beach, FL
NCT02004392Sunrise, FL
NCT02004392Princeton, NJ
NCT02004392Bennington, VT
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Who Is Running the Clinical Trial?
FORUM Pharmaceuticals Inc
Lead Sponsor
Trials
19
Patients Recruited
5,000+
Founded
2001
Headquarters
Waltham, Massachusetts, USA
Known For
Brain Disease Research
Top Products
Encenicline Hydrochloride (EVP-6124)