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

NCT00766363 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2012-04-20

Study results available
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Summary

This study is being conducted to determine the safety, tolerability, and pharmacokinetics (PK) of three different doses of an investigational medication, EVP-6124, in individuals with mild to moderate Alzheimer's disease who are also taking an Alzheimer's medication (AChEI \[acetylcholinesterase inhibitor\]: either donepezil or rivastigmine). In addition, PK of AChEI medications will be assessed. Cognitive function will be evaluated on an exploratory basis.

Conditions

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.

Sponsors & Collaborators

  • Syneos Health

    collaborator OTHER

  • FORUM Pharmaceuticals Inc

    lead INDUSTRY

Principal Investigators

  • David R. Hassmann, D.O. · Comprehensive Clinical Research

  • Beth Safirstein, M.D. · MD Clinical

  • Stephen Thein, Ph.D. · Pacific Research Network, Inc.

  • Jeffrey Apter, M.D. · Global Medical Institutes

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-10-31
Primary Completion
2009-03-31
Completion
2009-03-31

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00766363 on ClinicalTrials.gov