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Evaluation of Galantamine in the Treatment of Alzheimer's Disease

Primary Purpose

Alzheimer Disease

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Galantamine
Sponsored by
Janssen, LP
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer Disease focused on measuring Alzheimer's disease, Cholinergic agents, Cholinergic agonists, Cholinesterase inhibitors

Eligibility Criteria

0 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Probable Alzheimer's disease Mini-Mental State Examination (MMSE) 10-22 and ADAS greater than or equal to 18 Alzheimer's Disease Assessment Scale cognitive portion (ADAS-cog-11) score of at least 18 Opportunity for Activities of Daily Living Caregiver Subjects who live with or have regular daily visits from a responsible caregiver (visit frequency: preferably daily but at least 5 days/week). This includes a friend or relative or paid personnel. The caregiver should be capable of assisting with the subject's medication, prepared to attend with the subject for assessments, and willing to provide information about the subject. Exclusion Criteria: Conditions that could confound diagnosis Neurodegenerative disorders Acute cerebral trauma Psychiatric disease More than one infarct on CT/MRI scans History of alcohol or drug abuse Contradictions for a cholinominetic agent: seizures; ulcers; pulmonary conditions (including severe asthma); unstable angina; Afib; bradycardia less than 50; and AV block.

Sites / Locations

  • University of Alabama, Birmingham
  • James L. Frey, M.D., Ltd.
  • East Bay Neurology
  • University of Southern California
  • N. County Neurology Assoc.
  • University of California Irvine Medical Center
  • Pacific Research Network (PRN)
  • Affiliated Research Institute
  • INC
  • The Denver Center for Medical Research
  • Geriatric and Adult Psychiatry
  • Yale University, School of Medicine
  • Ocala Neurodiagnostic Center
  • Psychiatric Institute of Florida
  • Neurological Research Institute of Sarasota, PA
  • Suncoast Neuroscience Associates, Inc.
  • Premiere Research Institute
  • Chicago Center for Clinical Research
  • OSF Center for Senior Health
  • Indiana Alzheimer's University Clinic
  • The Johns Hopkins Hospital
  • Brigham Behavioral Neurology Group
  • Boston Clinical Research Center
  • University of Massachusetts Worcester
  • Oakwood Hospital and Medical Center
  • Michigan Medical P.C.
  • Regions Hospital
  • St. Louis University School of Medicine
  • Washington University
  • University of Nebraska
  • University of Medicine and Dentistry of New Jersey
  • Neurology Group of Bergen County
  • Overlook Hospital
  • Medwise Center
  • Neurological Associates of Albany, PC
  • East End Neuropsychiatric Associates
  • St. John's Episcopal Hospital
  • NYU Medical Center
  • University of Rochester
  • SUNY Stony Brook
  • Ohio State University
  • Clinical Pharmaceutical Trials
  • Oregon Health Sciences University
  • Pacific NW Clinical Research Center
  • Institute for Advanced Clinical Research
  • Neuroscience Center of Westmoreland Neurology
  • Brown University
  • Alzheimer's Research and Clinical Programs
  • University of Texas
  • Southwestern Vermont Medical Center
  • Memory Disorder Center of Vermont
  • Virginia Neuroscience Center
  • Prince William Neuroscience Center
  • Seattle Clinical Research Center
  • VAPS Health Care System

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
October 29, 1999
Last Updated
June 23, 2005
Sponsor
Janssen, LP
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1. Study Identification

Unique Protocol Identification Number
NCT00000172
Brief Title
Evaluation of Galantamine in the Treatment of Alzheimer's Disease
Official Title
Placebo Controlled Evaluation of Galantamine in the Treatment of Alzheimer's Disease: Safety and Efficacy Under a Slow-Titration Regimen
Study Type
Interventional

2. Study Status

Record Verification Date
November 2002
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Janssen, LP

4. Oversight

5. Study Description

Brief Summary
Galantamine is an experimental drug being evaluated in the United States for the treatment of Alzheimer's disease. Results from previous clinical trials suggest that galantamine may improve cognitive performance in individuals with Alzheimer's disease. It is not a cure for Alzheimer's disease. Nerve cells in the brain responsible for memory and cognitive function communicate using a chemical called acetylcholine. Research has shown that deterioration of cells that produce acetylcholine in the brain affects thought processes. Galantamine is thought to work in two ways to increase the amount of acetylcholine available in the brain. It inhibits an enzyme that breaks down acetylcholine and it also stimulates the nicotinic receptors in the brain to release more acetylcholine.
Detailed Description
After a 1-month single-blind run in phase, 910 subjects will be titrated, over a period of up to 8 weeks, to target doses of either: 0 (placebo); 24 mg/day galantamine; 16 mg/day galantamine; or 8 mg/day galantamine, in a 2:2:2:1 randomization ratio. Double-blind treatment will continue for a total of 5 months. The change from baseline in ADAS-cog and CIVIC-plus scores at Month 5 will be the primary efficacy endpoints. Tolerability will be evaluated based on adverse event reports, laboratory values, ECG, and vital signs with particular focus on the adverse event rates in the slower titration schedule for 24 mg/day. Efficacy of 24 mg/day and 16 mg/day galantamine will be compared with that of placebo. Information on the dose response relationship of galantamine will be evaluated.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease
Keywords
Alzheimer's disease, Cholinergic agents, Cholinergic agonists, Cholinesterase inhibitors

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Galantamine

10. Eligibility

Sex
All
Minimum Age & Unit of Time
0 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Probable Alzheimer's disease Mini-Mental State Examination (MMSE) 10-22 and ADAS greater than or equal to 18 Alzheimer's Disease Assessment Scale cognitive portion (ADAS-cog-11) score of at least 18 Opportunity for Activities of Daily Living Caregiver Subjects who live with or have regular daily visits from a responsible caregiver (visit frequency: preferably daily but at least 5 days/week). This includes a friend or relative or paid personnel. The caregiver should be capable of assisting with the subject's medication, prepared to attend with the subject for assessments, and willing to provide information about the subject. Exclusion Criteria: Conditions that could confound diagnosis Neurodegenerative disorders Acute cerebral trauma Psychiatric disease More than one infarct on CT/MRI scans History of alcohol or drug abuse Contradictions for a cholinominetic agent: seizures; ulcers; pulmonary conditions (including severe asthma); unstable angina; Afib; bradycardia less than 50; and AV block.
Facility Information:
Facility Name
University of Alabama, Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294-0017
Country
United States
Facility Name
James L. Frey, M.D., Ltd.
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85258
Country
United States
Facility Name
East Bay Neurology
City
Berkeley
State/Province
California
ZIP/Postal Code
94705
Country
United States
Facility Name
University of Southern California
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033-1039
Country
United States
Facility Name
N. County Neurology Assoc.
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
Facility Name
University of California Irvine Medical Center
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Pacific Research Network (PRN)
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Affiliated Research Institute
City
San Diego
State/Province
California
ZIP/Postal Code
92108
Country
United States
Facility Name
INC
City
San Diego
State/Province
California
ZIP/Postal Code
92122
Country
United States
Facility Name
The Denver Center for Medical Research
City
Denver
State/Province
Colorado
ZIP/Postal Code
80212
Country
United States
Facility Name
Geriatric and Adult Psychiatry
City
Hamden
State/Province
Connecticut
ZIP/Postal Code
06518
Country
United States
Facility Name
Yale University, School of Medicine
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States
Facility Name
Ocala Neurodiagnostic Center
City
Ocala
State/Province
Florida
ZIP/Postal Code
34471
Country
United States
Facility Name
Psychiatric Institute of Florida
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Neurological Research Institute of Sarasota, PA
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34239
Country
United States
Facility Name
Suncoast Neuroscience Associates, Inc.
City
St. Petersburg
State/Province
Florida
ZIP/Postal Code
33701
Country
United States
Facility Name
Premiere Research Institute
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33407
Country
United States
Facility Name
Chicago Center for Clinical Research
City
Chicago
State/Province
Illinois
ZIP/Postal Code
606104234
Country
United States
Facility Name
OSF Center for Senior Health
City
Peoria
State/Province
Illinois
ZIP/Postal Code
616033089
Country
United States
Facility Name
Indiana Alzheimer's University Clinic
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202-5111
Country
United States
Facility Name
The Johns Hopkins Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Brigham Behavioral Neurology Group
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Boston Clinical Research Center
City
Wellesley Hills
State/Province
Massachusetts
ZIP/Postal Code
02481
Country
United States
Facility Name
University of Massachusetts Worcester
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Facility Name
Oakwood Hospital and Medical Center
City
Dearborn
State/Province
Michigan
ZIP/Postal Code
48124
Country
United States
Facility Name
Michigan Medical P.C.
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Facility Name
Regions Hospital
City
St. Paul
State/Province
Minnesota
ZIP/Postal Code
55101
Country
United States
Facility Name
St. Louis University School of Medicine
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63104
Country
United States
Facility Name
Washington University
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63108
Country
United States
Facility Name
University of Nebraska
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
681985575
Country
United States
Facility Name
University of Medicine and Dentistry of New Jersey
City
Piscataway
State/Province
New Jersey
ZIP/Postal Code
088551392
Country
United States
Facility Name
Neurology Group of Bergen County
City
Ridgewood
State/Province
New Jersey
ZIP/Postal Code
07450
Country
United States
Facility Name
Overlook Hospital
City
Summit
State/Province
New Jersey
ZIP/Postal Code
07901
Country
United States
Facility Name
Medwise Center
City
West Long Branch
State/Province
New Jersey
ZIP/Postal Code
07764
Country
United States
Facility Name
Neurological Associates of Albany, PC
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
East End Neuropsychiatric Associates
City
Centereach
State/Province
New York
ZIP/Postal Code
11720
Country
United States
Facility Name
St. John's Episcopal Hospital
City
Far Rockaway
State/Province
New York
ZIP/Postal Code
11691
Country
United States
Facility Name
NYU Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
University of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14620
Country
United States
Facility Name
SUNY Stony Brook
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794-8121
Country
United States
Facility Name
Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Clinical Pharmaceutical Trials
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
741025428
Country
United States
Facility Name
Oregon Health Sciences University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97201-3098
Country
United States
Facility Name
Pacific NW Clinical Research Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97201
Country
United States
Facility Name
Institute for Advanced Clinical Research
City
Elkins Park
State/Province
Pennsylvania
ZIP/Postal Code
19027
Country
United States
Facility Name
Neuroscience Center of Westmoreland Neurology
City
Greensburg
State/Province
Pennsylvania
ZIP/Postal Code
15601
Country
United States
Facility Name
Brown University
City
Pawtucket
State/Province
Rhode Island
ZIP/Postal Code
02906
Country
United States
Facility Name
Alzheimer's Research and Clinical Programs
City
North Charleston
State/Province
South Carolina
ZIP/Postal Code
294066076
Country
United States
Facility Name
University of Texas
City
Dallas
State/Province
Texas
ZIP/Postal Code
752359070
Country
United States
Facility Name
Southwestern Vermont Medical Center
City
Bennington
State/Province
Vermont
ZIP/Postal Code
05201
Country
United States
Facility Name
Memory Disorder Center of Vermont
City
Colchester
State/Province
Vermont
ZIP/Postal Code
05446
Country
United States
Facility Name
Virginia Neuroscience Center
City
Alexandria
State/Province
Virginia
ZIP/Postal Code
22304
Country
United States
Facility Name
Prince William Neuroscience Center
City
Manassas
State/Province
Virginia
ZIP/Postal Code
20010
Country
United States
Facility Name
Seattle Clinical Research Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
VAPS Health Care System
City
Seattle
State/Province
Washington
ZIP/Postal Code
98108
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
10971048
Citation
Lilienfeld S, Parys W. Galantamine: additional benefits to patients with Alzheimer's disease. Dement Geriatr Cogn Disord. 2000 Sep;11 Suppl 1:19-27. doi: 10.1159/000051228.
Results Reference
background

Learn more about this trial

Evaluation of Galantamine in the Treatment of Alzheimer's Disease

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