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

Sponsor:	EnVivo Pharmaceuticals, Inc.
Collaborator:	INC Research Limited
Information provided by:	EnVivo Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:	NCT00766363

Purpose

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.

Condition	Intervention	Phase
Alzheimer's Disease Central Nervous System Diseases	Drug: EVP-6124 Drug: placebo	Phase I

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

Resource links provided by NLM:

Genetics Home Reference related topics: Alzheimer disease

MedlinePlus related topics: Alzheimer's Disease Neurologic Diseases

U.S. FDA Resources

Further study details as provided by EnVivo Pharmaceuticals, Inc.:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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

Enrollment:	48
Study Start Date:	September 2008
Study Completion Date:	March 2009
Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator EVP-6124 0.1 mg/one 0.1 mg capsule every day for 28 days.	Drug: EVP-6124
2: Active Comparator EVP-6124 0.3 mg/one 0.3 mg capsule every day for 28 days.	Drug: EVP-6124
3: Active Comparator EVP-6124 1.0 mg/one 1.0 mg capsule every day for 28 days.	Drug: EVP-6124
Placebo: Placebo Comparator	Drug: placebo

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.

Eligibility

Ages Eligible for Study:	50 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00766363

Locations

United States, California
Pacific Research Network, Inc.
San Diego, California, United States, 92103
United States, Florida
MD Clinical
Hallandale Beach, Florida, United States, 33009
United States, New Jersey
Comprehensive Clinical Research
Berlin, New Jersey, United States, 08009
Global Medical Institutes
Princeton, New Jersey, United States, 08540

Sponsors and Collaborators

EnVivo Pharmaceuticals, Inc.

INC Research Limited

Investigators

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

More Information

No publications provided

Responsible Party:	EnVivo Pharmaceuticals, Inc. ( Maria Gawryl, Ph.D., Program Executive )
Study ID Numbers:	EVP-6124-007
Study First Received:	October 1, 2008
Last Updated:	March 6, 2009
ClinicalTrials.gov Identifier:	NCT00766363 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by EnVivo Pharmaceuticals, Inc.:

Alzheimer's Disease
Central Nervous System Diseases
Cognition

Additional relevant MeSH terms:

Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Cholinergic Agonists
Nicotinic Agonists
Physiological Effects of Drugs
Alzheimer Disease
Nervous System Diseases
Central Nervous System Diseases

Brain Diseases
Neurodegenerative Diseases
Cholinergic Agents
Pharmacologic Actions
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Dementia
Tauopathies

ClinicalTrials.gov processed this record on November 05, 2009