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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01073228
Recruitment Status : Completed
First Posted : February 23, 2010
Last Update Posted : April 25, 2014
INC Research Limited
Information provided by (Responsible Party):
FORUM Pharmaceuticals Inc

Brief Summary:
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 or disease Intervention/treatment Phase
Alzheimer's Disease Central Nervous System Diseases Cognition Drug: EVP-6124 Drug: Placebo Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 409 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : April 2010
Actual Primary Completion Date : November 2011
Actual Study Completion Date : February 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Alzheimer's Disease Assessment Scale-Cognitive subscale-13 (ADAS-cog-13) [ Time Frame: Day -7, Baseline, 4, 12, 18, 23 Weeks ]

Secondary Outcome Measures :
  1. Alzheimer's Disease Assessment Scale-Cognitive subscale-11 [ Time Frame: 4, 12, 18, 23 Weeks ]
  2. Controlled Oral Word Association Test [ Time Frame: Day -7, Baseline, 4, 12, 18, 23 Weeks ]
  3. Category Fluency Test [ Time Frame: Day -7, Baseline, 4, 12, 18, 23 Weeks ]
  4. Clinical Dementia Rating Scale Sum of Boxes [ Time Frame: Day -7, Baseline, 4, 12, 18, 23 Weeks ]
  5. Alzheimer's Disease Cooperative Study-Activities of Daily Living [ Time Frame: Baseline, 4, 12, 18, 23 Weeks ]
  6. Neuropsychiatric Inventory [ Time Frame: Baseline, 12, 23 Weeks ]
  7. Mini-Mental State Exam [ Time Frame: Day -7, Baseline, 4, 12, 18, 23 Weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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:


  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01073228

  Hide Study 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
Brooklyn Medical Institute
Brooklyn, New York, United States, 11214
Social Psychiatry Research Institute
Brooklyn, New York, United States, 11235
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
Clinical Site 1
Bucharest, Romania
Clinical Site 2
Bucharest, Romania
Clinical Site 3
Bucharest, Romania
Clinical Site 4
Bucharest, Romania
Clinical Site 5
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 3
St Petersburg, Russian Federation, 194175
Clinical Site 4
St Petersburg, Russian Federation
Clinical Site 1
St. Petersburg, Russian Federation, 190005
Clinical Site 2
St. Petersburg, Russian Federation, 190103
Voronezh, Russian Federation, 394052
Yekaterinburg, Russian Federation
Clinical site 1
Belgrade, Serbia, 11000
Clinical Site 2
Belgrade, Serbia, 11000
Kragujevac, Serbia, 34000
Nis, Serbia, 18000
Dnipropetrovs'k, Ukraine, 490005
Donets'k, Ukraine, 83037
Kyiv, Ukraine, 04080
Kyiv, Ukraine, 04080
Odesa, Ukraine, 65006
Simferopol, Ukraine, 95006
Vinnytsya, Ukraine, 21005
Sponsors and Collaborators
FORUM Pharmaceuticals Inc
INC Research Limited

Responsible Party: FORUM Pharmaceuticals Inc Identifier: NCT01073228     History of Changes
Other Study ID Numbers: EVP-6124-010
First Posted: February 23, 2010    Key Record Dates
Last Update Posted: April 25, 2014
Last Verified: February 2013

Keywords provided by FORUM Pharmaceuticals Inc:
Alzheimer's disease
Central Nervous System diseases

Additional relevant MeSH terms:
Alzheimer Disease
Nervous System Diseases
Central Nervous System Diseases
Brain Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs