Search / Trial NCT00000172

Evaluation of Galantamine in the Treatment of Alzheimer's Disease

Launched by JANSSEN, LP · Oct 29, 1999

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Trial Information

Current as of June 14, 2024

Completed

Keywords

Alzheimer's Disease Cholinergic Agents Cholinergic Agonists Cholinesterase Inhibitors

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 titratio...

Gender

All

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.

Attachments

readout_NCT00000172_2024-06-14.pdf

4.5 MB

NCT00000172_study_protocol.pdf

4.5 MB

About company

The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

Contacts

JC

Jennifer Cobb

Immunology at National Institute of Allergy and Infectious Diseases (NIAID)

Locations

Los Angeles, California, United States

St. Louis, Missouri, United States

Portland, Oregon, United States

Pawtucket, Rhode Island, United States

Dallas, Texas, United States

Birmingham, Alabama, United States

Scottsdale, Arizona, United States

Berkeley, California, United States

Oceanside, California, United States

Orange, California, United States

San Diego, California, United States

San Diego, California, United States

San Diego, California, United States

Denver, Colorado, United States

Hamden, Connecticut, United States

New Haven, Connecticut, United States

Ocala, Florida, United States

Orlando, Florida, United States

Sarasota, Florida, United States

St. Petersburg, Florida, United States

West Palm Beach, Florida, United States

Chicago, Illinois, United States

Peoria, Illinois, United States

Indianapolis, Indiana, United States

Baltimore, Maryland, United States

Boston, Massachusetts, United States

Wellesley Hills, Massachusetts, United States

Worcester, Massachusetts, United States

Dearborn, Michigan, United States

Grand Rapids, Michigan, United States

St. Paul, Minnesota, United States

St. Louis, Missouri, United States

Omaha, Nebraska, United States

Piscataway, New Jersey, United States

Ridgewood, New Jersey, United States

Summit, New Jersey, United States

West Long Branch, New Jersey, United States

Albany, New York, United States

Centereach, New York, United States

Far Rockaway, New York, United States

New York, New York, United States

Rochester, New York, United States

Stony Brook, New York, United States

Columbus, Ohio, United States

Tulsa, Oklahoma, United States

Portland, Oregon, United States

Elkins Park, Pennsylvania, United States

Greensburg, Pennsylvania, United States

North Charleston, South Carolina, United States

Bennington, Vermont, United States

Colchester, Vermont, United States

Alexandria, Virginia, United States

Manassas, Virginia, United States

Seattle, Washington, United States

Seattle, Washington, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Reviews (48)

4.6

All reviews come from applied patients

5 stars
41
4 stars
6
3 stars
2
2 stars
0
1 stars
0
Leslie Alexander
20 September 2023

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Michael Foster
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Dries Vincent
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

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