Safety and Cognitive Function Study of EVP-6124 in Patients With Alzheimer's Disease - Tabular View

Tracking Information

First Received Date ^ICMJE

October 1, 2008

Last Updated Date

March 6, 2009

Start Date ^ICMJE

September 2008

Primary Completion Date

March 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Safety and tolerability of three doses of EVP-6124 and placebo administered daily for 28 days to subjects with Alzheimer's disease who are receiving concomitant treatment with an AChEI medication (donepezil or rivastigmine) [ Time Frame: 28 days ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00766363 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Cognitive function and drug to drug interaction [ Time Frame: 28 days ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Safety and Cognitive Function Study of EVP-6124 in Patients With Alzheimer's Disease

Official Title ^ICMJE

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

Brief Summary

This study is being conducted to determine the safety and tolerability 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:either donepezil or rivastigmine). In addition, cognitive performance and behavioral and psychiatric symptoms will be evaluated.

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 and cognitive testing will be performed inpatient and at each study visit.

Study Phase

Phase I

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety Study

Condition ^ICMJE

Alzheimer's Disease
Central Nervous System Diseases

Intervention ^ICMJE

Drug: EVP-6124
Drug: placebo

Study Arms / Comparison Groups

Active Comparator: EVP-6124 0.1 mg/one 0.1 mg capsule every day for 28 days.
Active Comparator: EVP-6124 0.3 mg/one 0.3 mg capsule every day for 28 days.
Active Comparator: EVP-6124 1.0 mg/one 1.0 mg capsule every day for 28 days.

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

March 2009

Primary Completion Date

March 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

male and post-menopausal or surgically sterile female pts
50-80 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 4 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 five years
Stroke within six months before screening, or concomitant with onset of dementia
Certain concomitant medications

Gender

Both

Ages

50 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00766363

Responsible Party

Maria Gawryl, Ph.D., Program Executive, EnVivo Pharmaceuticals, Inc.

Study ID Numbers ^ICMJE

EVP-6124-007

Study Sponsor ^ICMJE

EnVivo Pharmaceuticals, Inc.

Collaborators ^ICMJE

INC Research Limited

Investigators ^ICMJE

Principal Investigator:	David R. Hassmann, DO	Comprehensive Clinical Research
Principal Investigator:	Beth Safirstein, MD	MD Clinical
Principal Investigator:	Stephen Thein, Ph.D.	Pacific Research Network, Inc.
Principal Investigator:	Jeffrey Apter, MD	Global Medical Institutes

Information Provided By

EnVivo Pharmaceuticals, Inc.

Verification Date

March 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP