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

This study has been completed.
Sponsor:
Collaborator:
INC Research Limited
Information provided by (Responsible Party):
FORUM Pharmaceuticals Inc
ClinicalTrials.gov Identifier:
NCT01073228
First received: February 19, 2010
Last updated: March 28, 2014
Last verified: February 2013
  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:


Further study details as provided by FORUM 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
Active Comparator: EVP-6124 1 mg
one 1 mg capsule every day for 183 days
Drug: EVP-6124
Active Comparator: EVP-6124 2 mg
one 2 mg capsule every day for 183 days
Drug: EVP-6124
Placebo Comparator: Placebo
Placebo every day for 183 days
Drug: Placebo

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 screening 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  Hide Study Locations
Locations
United States, Arizona
HOPE Research Institute
Phoenix, Arizona, United States, 85050
United States, California
Catalina Research Institute
Chino, California, United States, 91710
ATP Clinical Research
Costa Mesa, California, United States, 92626
University of California, Irvine
Orange, California, United States, 92868
Radiant Research
Santa Rosa, California, United States, 95405
United States, Connecticut
Research Center for Clinical Studies, Inc.
Norwalk, Connecticut, United States, 06851
Chase Medical Research, LLC
Waterbury, Connecticut, United States, 06708
United States, Florida
Meridien Research
Brooksville, Florida, United States, 34601
Brain Matters Research
Delray Beach, Florida, United States, 33445
MD Clinical
Hallandale Beach, Florida, United States, 33009
Galiz Research
Miami Springs, Florida, United States, 33166
Renstar Medical Research
Ocala, Florida, United States, 34471
Compass Research, LLC
Orlando, Florida, United States, 32806
United States, New Jersey
Princeton Medical Institute
Princeton, New Jersey, United States, 08540
Memory Enhancement Center of NJ
Toms River, New Jersey, United States, 08755
United States, New York
Social Psychiatry Research Institute
Brooklyn, New York, United States, 11235
Brooklyn Medical Institute
Brooklyn, New York, United States, 11214
Advanced Bio Behavioral Sciences Inc.
Elmsford, New York, United States, 10523
University of Rochester Medical Center at MCH
Rochester, New York, United States, 14620
United States, Ohio
Columbus Research and Wellness Institute
Columbus, Ohio, United States, 31909
United States, Oregon
Summit Research Network
Portland, Oregon, United States, 97210
United States, Texas
FutureSearch Trials of Dallas, L.P.
Dallas, Texas, United States, 75231
Grayline Clinical Drug Trials
Wichita Falls, Texas, United States, 76309
United States, Vermont
The Memory Clinic
Bennington, Vermont, United States, 05201
United States, Virginia
The Center for Excellence in Aging and Geriatric Health
Williamsburg, Virginia, United States, 23185
Romania
Clinical Site 2
Bucharest, Romania
Clinical Site 5
Bucharest, Romania
Clinical Site 1
Bucharest, Romania
Clinical Site 3
Bucharest, Romania
Clinical Site 4
Bucharest, Romania
Iasi, Romania, 700282
Oradea, Romania, 410154
Tirgu Mures, Romania
Russian Federation
Kazan, Russian Federation, 420064
Clinical Site 1
Moscow, Russian Federation, 115552
Clinical Site 2
Moscow, Russian Federation
Saratov, Russian Federation, 410060
Clinical Site 4
St Petersburg, Russian Federation
Clinical Site 3
St Petersburg, Russian Federation, 194175
Clinical Site 2
St. Petersburg, Russian Federation, 190103
Clinical Site 1
St. Petersburg, Russian Federation, 190005
Voronezh, Russian Federation, 394052
Yekaterinburg, Russian Federation
Serbia
Clinical site 1
Belgrade, Serbia, 11000
Clinical Site 2
Belgrade, Serbia, 11000
Kragujevac, Serbia, 34000
Nis, Serbia, 18000
Ukraine
Dnipropetrovs'k, Ukraine, 490005
Donets'k, Ukraine, 83037
(2)
Kyiv, Ukraine, 04080
(1)
Kyiv, Ukraine, 04080
Odesa, Ukraine, 65006
Simferopol, Ukraine, 95006
Vinnytsya, Ukraine, 21005
Sponsors and Collaborators
FORUM Pharmaceuticals Inc
INC Research Limited
  More Information

No publications provided

Responsible Party: FORUM 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 28, 2014
Health Authority: United States: Food and Drug Administration
Russia: Ministry of Health 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 FORUM Pharmaceuticals Inc:
Alzheimer's disease
Central Nervous System diseases
Cognition

Additional relevant MeSH terms:
Alzheimer Disease
Central Nervous System Diseases
Nervous System Diseases
Brain Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Dementia
Mental Disorders
Neurodegenerative Diseases
Tauopathies
Nicotinic Agonists
Cholinergic Agents
Cholinergic Agonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 20, 2014