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

February 19, 2010
March 28, 2014
April 2010
November 2011   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01073228 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Safety and Cognitive Function Study of EVP-6124 in Patients With Mild to Moderate Alzheimer's Disease
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

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Alzheimer's Disease
  • Central Nervous System Diseases
  • Cognition
  • Drug: EVP-6124
  • Drug: Placebo
  • Active Comparator: EVP-6124 0.3 mg
    one 0.3 mg capsule every day for 183 days
    Intervention: Drug: EVP-6124
  • Active Comparator: EVP-6124 1 mg
    one 1 mg capsule every day for 183 days
    Intervention: Drug: EVP-6124
  • Active Comparator: EVP-6124 2 mg
    one 2 mg capsule every day for 183 days
    Intervention: Drug: EVP-6124
  • Placebo Comparator: Placebo
    Placebo every day for 183 days
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
409
February 2012
November 2011   (final data collection date for primary outcome measure)

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
Both
50 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
Romania,   Russian Federation,   Ukraine,   Serbia,   United States
 
NCT01073228
EVP-6124-010
No
FORUM Pharmaceuticals Inc
FORUM Pharmaceuticals Inc
INC Research Limited
Not Provided
FORUM Pharmaceuticals Inc
February 2013

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