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

Sponsor:	EnVivo Pharmaceuticals, Inc.
Collaborator:	INC Research Limited
Information provided by (Responsible Party):	EnVivo Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:	NCT01073228

Purpose

This study is being conducted to determine the safety and effect on cognitive function of the investigational medication, EVP-6124, in individuals with mild to moderate probable Alzheimer's disease.

Condition	Intervention	Phase
Alzheimer's Disease Central Nervous System Diseases Cognition	Drug: EVP-6124 Drug: Placebo	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	A Randomized, Double-blind, Placebo-Controlled, Parallel, 24-Week, Phase 2 Study of Three Different Doses of an Alpha-7 Nicotinic Acetylcholine Receptor Agonist (EVP-6124) or Placebo in Subjects With Mild to Moderate Probable Alzheimer's Disease

Resource links provided by NLM:

MedlinePlus related topics: Alzheimer's Disease Neurologic Diseases

U.S. FDA Resources

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

Primary Outcome Measures:

Alzheimer's Disease Assessment Scale-Cognitive subscale-13 (ADAS-cog-13) [ Time Frame: Day -7, Baseline, 4, 12, 18, 23 Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Alzheimer's Disease Assessment Scale-Cognitive subscale-11 [ Time Frame: 4, 12, 18, 23 Weeks ] [ Designated as safety issue: No ]
Controlled Oral Word Association Test [ Time Frame: Day -7, Baseline, 4, 12, 18, 23 Weeks ] [ Designated as safety issue: No ]
Category Fluency Test [ Time Frame: Day -7, Baseline, 4, 12, 18, 23 Weeks ] [ Designated as safety issue: No ]
Clinical Dementia Rating Scale Sum of Boxes [ Time Frame: Day -7, Baseline, 4, 12, 18, 23 Weeks ] [ Designated as safety issue: No ]
Alzheimer's Disease Cooperative Study-Activities of Daily Living [ Time Frame: Baseline, 4, 12, 18, 23 Weeks ] [ Designated as safety issue: No ]
Neuropsychiatric Inventory [ Time Frame: Baseline, 12, 23 Weeks ] [ Designated as safety issue: No ]
Mini-Mental State Exam [ Time Frame: Day -7, Baseline, 4, 12, 18, 23 Weeks ] [ Designated as safety issue: No ]

Enrollment:	409
Study Start Date:	April 2010
Study Completion Date:	February 2012
Primary Completion Date:	November 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: EVP-6124 0.3 mg one 0.3 mg capsule every day for 183 days	Drug: EVP-6124 Arms: 1,2,3
Active Comparator: EVP-6124 1 mg one 1 mg capsule every day for 183 days	Drug: EVP-6124 Arms: 1,2,3
Active Comparator: EVP-6124 2 mg one 2 mg capsule every day for 183 days	Drug: EVP-6124 Arms: 1,2,3
Placebo Comparator: Placebo Placebo every day for 183 days	Drug: EVP-6124 Arms: 1,2,3 Drug: Placebo Arm: 4

Detailed Description:

This is a randomized, double-blind, placebo-controlled, parallel, 24-week, Phase 2 safety/efficacy study in which three dose levels of EVP-6124 or placebo will be evaluated. Eligible for enrollment will be patients who meet clinical criteria for mild to moderate probable Alzheimer's disease who are either receiving treatment with AChEI medication at a stable dose or who are not presently taking any AChEI or memantine co-medication.

Patients will be randomized to one of the following groups: 0.3 mg, 1 mg or 2 mg or Placebo. Approximately 400 subjects will be randomized to the 4 treatment groups. Study drug will be supplied as capsules and will be orally administered once daily for a total of 24 weeks.

Eligibility

Ages Eligible for Study:	50 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Subjects with Probable Alzheimer's disease
Mini-Mental State Examination (MMSE) score of 14 to 24 inclusive at screening and a CDR-SB score ≥2 at the Day 7 assessment
Modified Hachinski Ischemic Score (mHIS) ≤4 at screening
Female subjects are ≥1 year post-menopausal or are surgically sterile
Caregiver available; if not living in the same household, caregiver sees subject at least four times each week
Subject living at home, senior residential setting, or an institutional setting without the need for continuous nursing care
General health status acceptable for participation in a 24 week clinical trial be administered

Exclusion Criteria:

General

Participation in another therapeutic clinical trial within 30 days before Baseline
Prior participation in an amyloid vaccination clinical study
Inability to swallow capsules
Likely inability to complete 24 week study
Inability to be ≥75% compliant with single-blind placebo run-in medication
Inability to adequately perform cognitive tests
History of significant cardiovascular disease
Major depression
Psychosis
History of stroke within 18 months of screening
Head trauma
Inability to perform any screening or baseline evaluations

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01073228

Show 54 Study Locations

Sponsors and Collaborators

EnVivo Pharmaceuticals, Inc.

INC Research Limited

More Information

No publications provided

Responsible Party:	EnVivo Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:	NCT01073228 History of Changes
Other Study ID Numbers:	EVP-6124-010
Study First Received:	February 19, 2010
Last Updated:	March 30, 2012
Health Authority:	United States: Food and Drug Administration Russia: Ministry of Health and Social Development of the Russian Federation Romania: National Medicines Agency Ukraine: State Pharmacological Center - Ministry of Health Serbia and Montenegro: Agency for Drugs and Medicinal Devices

Keywords provided by EnVivo Pharmaceuticals, Inc.:

Alzheimer's disease
Central Nervous System diseases
Cognition

Additional relevant MeSH terms:

Alzheimer Disease
Central Nervous System Diseases
Nervous System Diseases
Dementia
Brain Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders

Mental Disorders
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 24, 2012