Safety, Tolerability, and Pharmacokinetic Study of EVP-6124 in Patients With Alzheimer's Disease

PHASE1CompletedINTERVENTIONAL
Enrollment

49

Participants

Timeline

Start Date

October 31, 2008

Primary Completion Date

March 31, 2009

Study Completion Date

March 31, 2009

Conditions
Alzheimer's DiseaseCentral Nervous System Diseases
Interventions
DRUG

EVP-6124 (0.1 mg/day)

EVP-6124 was administered as one 0.1 mg capsule per day for 28 days.

DRUG

EVP-6124 (0.3 mg/day)

EVP-6124 was administered as one 0.3 mg capsule every day for 28 days.

DRUG

EVP-6124 (1.0 mg/day)

EVP-6124 was administered as one 1.0 mg capsule every day for 28 days.

DRUG

Comparator: Placebo

Matching placebo was administered as one capsule per day for 28 days.

DRUG

Donepezil

Concomitant therapy with donepezil at a stable dose, taken daily at the same time or immediately after the assigned EVP-6124 dose. Patients must have been taking concomitant therapy for at least 3 months prior to enrollment to be eligible for the study.

DRUG

Rivastigmine

Concomitant therapy with rivastigmine at a stable dose, taken daily at the same time or immediately after the assigned EVP-6124 dose. Patients must have been taking concomitant therapy for at least 3 months prior to enrollment to be eligible for the study.

Trial Locations (4)

33009

MD Clinical, Hallandale

92103

Pacific Research Network, Inc., San Diego

08009

Comprehensive Clinical Research, Berlin

08540

Global Medical Institutes, LLC, Princeton

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Syneos Health

OTHER

lead

FORUM Pharmaceuticals Inc

INDUSTRY