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

Primary Purpose

Alzheimer's Disease, Central Nervous System Diseases, Cognition

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
EVP-6124
Placebo
Sponsored by
FORUM Pharmaceuticals Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer's Disease focused on measuring Alzheimer's disease, Central Nervous System diseases, Cognition

Eligibility Criteria

50 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • HOPE Research Institute
  • Catalina Research Institute
  • ATP Clinical Research
  • University of California, Irvine
  • Radiant Research
  • Research Center for Clinical Studies, Inc.
  • Chase Medical Research, LLC
  • Meridien Research
  • Brain Matters Research
  • MD Clinical
  • Galiz Research
  • Renstar Medical Research
  • Compass Research, LLC
  • Princeton Medical Institute
  • Memory Enhancement Center of NJ
  • Brooklyn Medical Institute
  • Social Psychiatry Research Institute
  • Advanced Bio Behavioral Sciences Inc.
  • University of Rochester Medical Center at MCH
  • Columbus Research and Wellness Institute
  • Summit Research Network
  • FutureSearch Trials of Dallas, L.P.
  • Grayline Clinical Drug Trials
  • The Memory Clinic
  • The Center for Excellence in Aging and Geriatric Health
  • Clinical Site 1
  • Clinical Site 2
  • Clinical Site 3
  • Clinical Site 4
  • Clinical Site 5
  • Clinical Site 1
  • Clinical Site 2
  • Clinical Site 3
  • Clinical Site 4
  • Clinical Site 1
  • Clinical Site 2
  • Clinical site 1
  • Clinical Site 2
  • (1)
  • (2)

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

EVP-6124 0.3 mg

EVP-6124 1 mg

EVP-6124 2 mg

Placebo

Arm Description

one 0.3 mg capsule every day for 183 days

one 1 mg capsule every day for 183 days

one 2 mg capsule every day for 183 days

Placebo every day for 183 days

Outcomes

Primary Outcome Measures

Alzheimer's Disease Assessment Scale-Cognitive subscale-13 (ADAS-cog-13)

Secondary Outcome Measures

Alzheimer's Disease Assessment Scale-Cognitive subscale-11
Controlled Oral Word Association Test
Category Fluency Test
Clinical Dementia Rating Scale Sum of Boxes
Alzheimer's Disease Cooperative Study-Activities of Daily Living
Neuropsychiatric Inventory
Mini-Mental State Exam

Full Information

First Posted
February 19, 2010
Last Updated
March 28, 2014
Sponsor
FORUM Pharmaceuticals Inc
Collaborators
INC Research Limited
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1. Study Identification

Unique Protocol Identification Number
NCT01073228
Brief Title
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

2. Study Status

Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
February 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
FORUM Pharmaceuticals Inc
Collaborators
INC Research Limited

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease, Central Nervous System Diseases, Cognition
Keywords
Alzheimer's disease, Central Nervous System diseases, Cognition

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
409 (Actual)

8. Arms, Groups, and Interventions

Arm Title
EVP-6124 0.3 mg
Arm Type
Active Comparator
Arm Description
one 0.3 mg capsule every day for 183 days
Arm Title
EVP-6124 1 mg
Arm Type
Active Comparator
Arm Description
one 1 mg capsule every day for 183 days
Arm Title
EVP-6124 2 mg
Arm Type
Active Comparator
Arm Description
one 2 mg capsule every day for 183 days
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo every day for 183 days
Intervention Type
Drug
Intervention Name(s)
EVP-6124
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Alzheimer's Disease Assessment Scale-Cognitive subscale-13 (ADAS-cog-13)
Time Frame
Day -7, Baseline, 4, 12, 18, 23 Weeks
Secondary Outcome Measure Information:
Title
Alzheimer's Disease Assessment Scale-Cognitive subscale-11
Time Frame
4, 12, 18, 23 Weeks
Title
Controlled Oral Word Association Test
Time Frame
Day -7, Baseline, 4, 12, 18, 23 Weeks
Title
Category Fluency Test
Time Frame
Day -7, Baseline, 4, 12, 18, 23 Weeks
Title
Clinical Dementia Rating Scale Sum of Boxes
Time Frame
Day -7, Baseline, 4, 12, 18, 23 Weeks
Title
Alzheimer's Disease Cooperative Study-Activities of Daily Living
Time Frame
Baseline, 4, 12, 18, 23 Weeks
Title
Neuropsychiatric Inventory
Time Frame
Baseline, 12, 23 Weeks
Title
Mini-Mental State Exam
Time Frame
Day -7, Baseline, 4, 12, 18, 23 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
HOPE Research Institute
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85050
Country
United States
Facility Name
Catalina Research Institute
City
Chino
State/Province
California
ZIP/Postal Code
91710
Country
United States
Facility Name
ATP Clinical Research
City
Costa Mesa
State/Province
California
ZIP/Postal Code
92626
Country
United States
Facility Name
University of California, Irvine
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Radiant Research
City
Santa Rosa
State/Province
California
ZIP/Postal Code
95405
Country
United States
Facility Name
Research Center for Clinical Studies, Inc.
City
Norwalk
State/Province
Connecticut
ZIP/Postal Code
06851
Country
United States
Facility Name
Chase Medical Research, LLC
City
Waterbury
State/Province
Connecticut
ZIP/Postal Code
06708
Country
United States
Facility Name
Meridien Research
City
Brooksville
State/Province
Florida
ZIP/Postal Code
34601
Country
United States
Facility Name
Brain Matters Research
City
Delray Beach
State/Province
Florida
ZIP/Postal Code
33445
Country
United States
Facility Name
MD Clinical
City
Hallandale Beach
State/Province
Florida
ZIP/Postal Code
33009
Country
United States
Facility Name
Galiz Research
City
Miami Springs
State/Province
Florida
ZIP/Postal Code
33166
Country
United States
Facility Name
Renstar Medical Research
City
Ocala
State/Province
Florida
ZIP/Postal Code
34471
Country
United States
Facility Name
Compass Research, LLC
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Princeton Medical Institute
City
Princeton
State/Province
New Jersey
ZIP/Postal Code
08540
Country
United States
Facility Name
Memory Enhancement Center of NJ
City
Toms River
State/Province
New Jersey
ZIP/Postal Code
08755
Country
United States
Facility Name
Brooklyn Medical Institute
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11214
Country
United States
Facility Name
Social Psychiatry Research Institute
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11235
Country
United States
Facility Name
Advanced Bio Behavioral Sciences Inc.
City
Elmsford
State/Province
New York
ZIP/Postal Code
10523
Country
United States
Facility Name
University of Rochester Medical Center at MCH
City
Rochester
State/Province
New York
ZIP/Postal Code
14620
Country
United States
Facility Name
Columbus Research and Wellness Institute
City
Columbus
State/Province
Ohio
ZIP/Postal Code
31909
Country
United States
Facility Name
Summit Research Network
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
FutureSearch Trials of Dallas, L.P.
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Grayline Clinical Drug Trials
City
Wichita Falls
State/Province
Texas
ZIP/Postal Code
76309
Country
United States
Facility Name
The Memory Clinic
City
Bennington
State/Province
Vermont
ZIP/Postal Code
05201
Country
United States
Facility Name
The Center for Excellence in Aging and Geriatric Health
City
Williamsburg
State/Province
Virginia
ZIP/Postal Code
23185
Country
United States
Facility Name
Clinical Site 1
City
Bucharest
Country
Romania
Facility Name
Clinical Site 2
City
Bucharest
Country
Romania
Facility Name
Clinical Site 3
City
Bucharest
Country
Romania
Facility Name
Clinical Site 4
City
Bucharest
Country
Romania
Facility Name
Clinical Site 5
City
Bucharest
Country
Romania
City
Iasi
ZIP/Postal Code
700282
Country
Romania
City
Oradea
ZIP/Postal Code
410154
Country
Romania
City
Tirgu Mures
Country
Romania
City
Kazan
ZIP/Postal Code
420064
Country
Russian Federation
Facility Name
Clinical Site 1
City
Moscow
ZIP/Postal Code
115552
Country
Russian Federation
Facility Name
Clinical Site 2
City
Moscow
Country
Russian Federation
City
Saratov
ZIP/Postal Code
410060
Country
Russian Federation
Facility Name
Clinical Site 3
City
St Petersburg
ZIP/Postal Code
194175
Country
Russian Federation
Facility Name
Clinical Site 4
City
St Petersburg
Country
Russian Federation
Facility Name
Clinical Site 1
City
St. Petersburg
ZIP/Postal Code
190005
Country
Russian Federation
Facility Name
Clinical Site 2
City
St. Petersburg
ZIP/Postal Code
190103
Country
Russian Federation
City
Voronezh
ZIP/Postal Code
394052
Country
Russian Federation
City
Yekaterinburg
Country
Russian Federation
Facility Name
Clinical site 1
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Clinical Site 2
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
City
Kragujevac
ZIP/Postal Code
34000
Country
Serbia
City
Nis
ZIP/Postal Code
18000
Country
Serbia
City
Dnipropetrovs'k
ZIP/Postal Code
490005
Country
Ukraine
City
Donets'k
ZIP/Postal Code
83037
Country
Ukraine
Facility Name
(1)
City
Kyiv
ZIP/Postal Code
04080
Country
Ukraine
Facility Name
(2)
City
Kyiv
ZIP/Postal Code
04080
Country
Ukraine
City
Odesa
ZIP/Postal Code
65006
Country
Ukraine
City
Simferopol
ZIP/Postal Code
95006
Country
Ukraine
City
Vinnytsya
ZIP/Postal Code
21005
Country
Ukraine

12. IPD Sharing Statement

Learn more about this trial

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

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