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

Information source: FORUM Pharmaceuticals Inc
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Alzheimer's Disease; Central Nervous System Diseases

Intervention: EVP-6124 (0.1 mg/day) (Drug); EVP-6124 (0.3 mg/day) (Drug); EVP-6124 (1.0 mg/day) (Drug); Comparator: Placebo (Drug); Donepezil (Drug); Rivastigmine (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: FORUM Pharmaceuticals Inc

Official(s) and/or principal investigator(s):
David R. Hassmann, D.O., Principal Investigator, Affiliation: Comprehensive Clinical Research
Beth Safirstein, M.D., Principal Investigator, Affiliation: MD Clinical
Stephen Thein, Ph.D., Principal Investigator, Affiliation: Pacific Research Network, Inc.
Jeffrey Apter, M.D., Principal Investigator, Affiliation: Global Medical Institutes

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.

Clinical Details

Official title: A Randomized, Double-Blind, Placebo-Controlled, Ascending-Dose Phase 1b Safety Study of Three Different Doses of an Alpha-7 Nicotinic Acetylcholine Receptor Agonist (EVP-6124) or Placebo in Patients With Mild to Moderate Probable Alzheimer's Disease

Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Safety and Tolerability of Multiple Doses of EVP-6124 or Placebo in Subjects With Alzheimer's Disease

Secondary outcome:

EVP-6124 PK Data Following the First Dose of EVP-6124 - Maximum Concentration (Cmax)

EVP-6124 PK Data Following the First Dose of EVP-6124 - Time to Maximum Concentration (Tmax)

EVP-6124 PK Data Following the First Dose of EVP-6124 - Area Under the Curve (AUC[0-24 h])

Donepezil PK Data Following the First Dose of EVP-6124 - Maximum Concentration (Cmax)

Donepezil PK Data Following the First Dose of EVP-6124 - Time to Maximum Concentration (Tmax)

Donepezil PK Data Following the First Dose of EVP-6124 - Area Under the Curve (AUC[0-24 h])

Rivastigmine PK Data Following the First Dose of EVP-6124 - Maximum Concentration (Cmax)

Rivastigmine PK Data Following the First Dose of EVP-6124 - Time to Maximum Concentration (Tmax)

Rivastigmine PK Data Following the First Dose of EVP-6124 - Area Under the Curve (AUC[0-24 h])

Detailed description: This is a randomized, double-blind, placebo-controlled, Phase 1b safety study of three dose levels of EVP-6124 in subjects with mild or moderate Alzheimer's disease and who are taking an AChEI medication (donepezil or rivastigmine). Study drug will be supplied as capsules and will be orally administered once daily for a

total of 28 days. Eligible subjects will be admitted to an inpatient study unit on Day - 2

(two days before the first dose of study drug is administered) and will remain confined to the inpatient study unit for a total of five days. Starting on Day 4, subjects will continue the study in the outpatient setting, with study visits on Days 7, 14, 21, and 28. Safety assessments, PK sampling, and cognitive testing will be performed inpatient and at each study visit.

Eligibility

Minimum age: 50 Years. Maximum age: 90 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- male and post-menopausal or surgically sterile female pts

- 50-90 yrs old, who meet clinical criteria for probable Alzheimer's disease

(Mini-Mental State Examination of 18-26; Hachinski Ischemic Score ≤4)

- must be taking donepezil or rivastigmine for at least 3 mos.

Exclusion Criteria:

- Unstable medical condition that is clinically significant in the judgment of the

investigator; major organ system dysfunction

- Untreated hypothyroidism

- Insufficiently controlled diabetes mellitus

- Diagnosis of major depression requiring antidepressant medications within the last 5

years

- Stroke within 6 months before screening, or concomitant with onset of dementia

- Certain concomitant medications

Locations and Contacts

Pacific Research Network, Inc., San Diego, California 92103, United States

MD Clinical, Hallandale Beach, Florida 33009, United States

Comprehensive Clinical Research, Berlin, New Jersey 08009, United States

Global Medical Institutes, LLC, Princeton, New Jersey 08540, United States

Additional Information

Starting date: October 2008
Last updated: April 18, 2012

Page last updated: August 23, 2015

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