Clinical trial NCT01073228: Safety and Cognitive Function Study of EVP-6124 in Patients With Mild to Moderate Alzheimer's Disease
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Alzheimer's Disease
Central Nervous System Diseases
Cognition
Keywords: Alzheimer's disease
Central Nervous System diseases
Cognition
Lead sponsor: FORUM Pharmaceuticals Inc
Sponsor class: INDUSTRY
Collaborators: name: INC Research Limited
First posted: 2010-02-23
Enrollment: 409
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: Alzheimer's Disease Assessment Scale-Cognitive subscale-13 (ADAS-cog-13)
timeFrame: Day -7, Baseline, 4, 12, 18, 23 Weeks
Secondary outcomes:
measure: Alzheimer's Disease Assessment Scale-Cognitive subscale-11
timeFrame: 4, 12, 18, 23 Weeks
measure: Controlled Oral Word Association Test
timeFrame: Day -7, Baseline, 4, 12, 18, 23 Weeks
measure: Category Fluency Test
timeFrame: Day -7, Baseline, 4, 12, 18, 23 Weeks
measure: Clinical Dementia Rating Scale Sum of Boxes
timeFrame: Day -7, Baseline, 4, 12, 18, 23 Weeks
measure: Alzheimer's Disease Cooperative Study-Activities of Daily Living
timeFrame: Baseline, 4, 12, 18, 23 Weeks
measure: Neuropsychiatric Inventory
timeFrame: Baseline, 12, 23 Weeks
measure: Mini-Mental State Exam
timeFrame: Day -7, Baseline, 4, 12, 18, 23 Weeks
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: HOPE Research Institute
state: Arizona
city: Chino
country: United States
facility: Catalina Research Institute
state: California
city: Costa Mesa
country: United States
facility: ATP Clinical Research
state: California
city: Orange
country: United States
facility: University of California, Irvine
state: California
city: Santa Rosa
country: United States
facility: Radiant Research
state: California
city: Norwalk
country: United States
facility: Research Center for Clinical Studies, Inc.
state: Connecticut
city: Waterbury
country: United States
facility: Chase Medical Research, LLC
state: Connecticut
city: Brooksville
country: United States
facility: Meridien Research
state: Florida
city: Delray Beach
country: United States
facility: Brain Matters Research
state: Florida
city: Hallandale Beach
country: United States
facility: MD Clinical
state: Florida
city: Miami Springs
country: United States
facility: Galiz Research
state: Florida
city: Ocala
country: United States
facility: Renstar Medical Research
state: Florida
city: Orlando
country: United States
facility: Compass Research, LLC
state: Florida
city: Princeton
country: United States
facility: Princeton Medical Institute
state: New Jersey
city: Toms River
country: United States
facility: Memory Enhancement Center of NJ
state: New Jersey
city: Brooklyn
country: United States
facility: Brooklyn Medical Institute
state: New York
city: Brooklyn
country: United States
facility: Social Psychiatry Research Institute
state: New York
city: Elmsford
country: United States
facility: Advanced Bio Behavioral Sciences Inc.
state: New York
city: Rochester
country: United States
facility: University of Rochester Medical Center at MCH
state: New York
city: Columbus
country: United States
facility: Columbus Research and Wellness Institute
state: Ohio
city: Portland
country: United States
facility: Summit Research Network
state: Oregon
city: Dallas
country: United States
facility: FutureSearch Trials of Dallas, L.P.
state: Texas
city: Wichita Falls
country: United States
facility: Grayline Clinical Drug Trials
state: Texas
city: Bennington
country: United States
facility: The Memory Clinic
state: Vermont
city: Williamsburg
country: United States
facility: The Center for Excellence in Aging and Geriatric Health
state: Virginia
city: Bucharest
country: Romania
facility: Clinical Site 1
city: Bucharest
country: Romania
facility: Clinical Site 2
city: Bucharest
country: Romania
facility: Clinical Site 3
city: Bucharest
country: Romania
facility: Clinical Site 4
city: Bucharest
country: Romania
facility: Clinical Site 5
city: Iasi
country: Romania
city: Oradea
country: Romania
city: Tirgu Mures
country: Romania
city: Kazan
country: Russian Federation
city: Moscow
country: Russian Federation
facility: Clinical Site 1
city: Moscow
country: Russian Federation
facility: Clinical Site 2
city: Saratov
country: Russian Federation
city: St Petersburg
country: Russian Federation
facility: Clinical Site 3
city: St Petersburg
country: Russian Federation
facility: Clinical Site 4
city: St. Petersburg
country: Russian Federation
facility: Clinical Site 1
city: St. Petersburg
country: Russian Federation
facility: Clinical Site 2
city: Voronezh
country: Russian Federation
city: Yekaterinburg
country: Russian Federation
city: Belgrade
country: Serbia
facility: Clinical site 1
city: Belgrade
country: Serbia
facility: Clinical Site 2
city: Kragujevac
country: Serbia
city: Nis
country: Serbia
city: Dnipropetrovs'k
country: Ukraine
city: Donets'k
country: Ukraine
city: Kyiv
country: Ukraine
facility: (1)
city: Kyiv
country: Ukraine
facility: (2)
city: Odesa
country: Ukraine
city: Simferopol
country: Ukraine
city: Vinnytsya
country: Ukraine
Study officials:
References: