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Cognitive and Neurophysiological Effects of Raloxifene in Alzheimer's Disease

This study has been completed.

Sponsored by: University of Wisconsin, Madison
Information provided by: National Institute on Aging (NIA)
ClinicalTrials.gov Identifier: NCT00065767
  Purpose

The aim of this study is to determine the effectiveness of treatment with raloxifene, an estrogen-like medication approved by the Food and Drug Administration for the treatment of osteoporosis, in improving memory and the ability to live independently in postmenopausal women with Alzheimer's disease.


Condition Intervention Phase
Alzheimer Disease
Drug: Raloxifene
Phase II
Phase III

Genetics Home Reference related topics:   Alzheimer disease   

MedlinePlus related topics:   Alzheimer's Disease    Memory   

ChemIDplus related topics:   Raloxifene    Raloxifene hydrochloride   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title:   Cognitive and Neurophysiological Effects of Raloxifene in Alzheimer's Disease

Further study details as provided by National Institute on Aging (NIA):

Estimated Enrollment:   20
Study Start Date:   September 2001
Estimated Study Completion Date:   December 2004

Detailed Description:

The aim of this study is to determine the effectiveness of treatment with raloxifene, an estrogen-like medication (classified as Selective Estrogen Receptor Modulators (SER's)) approved by the Food and Drug Administration for the treatment of osteoporosis, in improving memory and the ability to live independently in postmenopausal women with Alzheimer's disease. Patients who volunteer for this study will need to visit the clinic 7 times (participate) over a period of five months and will receive either raloxifene or a harmless, inactive pill called a placebo. Neither the volunteers nor the study staff will know which type of pill a patient receives. Patients must be generally healthy and have mild-to-moderate dementia. There must be a patient caregiver who can watch for side effects and ensure that the patient takes the study pills on schedule over a period of three months.

Patients will undergo neuropsychological tests and an evaluation of the ability to live independently at each visit as well as laboratory evaluations, such as the taking of blood. Each visit will last approximately 3 hours. A total of 20 patients is being recruited to participate in this study at the University of Wisconsin.

  Eligibility
Ages Eligible for Study:   55 Years to 90 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

  • Postmenopausal women with Alzheimer's disease and without other dementias (diagnosed by study staff or from an outside clinic)
  • Mini Mental Status Exam score greater than 15/30

Exclusion Criteria:

  • History of deep vein thrombosis or blot clots
  • Diabetes
  • Active heart disease or stroke
  • Liver problems including hepatitis
  • Severe vision or hearing problems
  • Tobacco use
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00065767

Locations
United States, Wisconsin
University of Wisconsin Memory Research Program    
      Madison, Wisconsin, United States, 53705

Sponsors and Collaborators
University of Wisconsin, Madison

Investigators
Principal Investigator:     Sanjay Asthana, MD     William S. Middleton VA Hospital, University of Wisconsin Memory Research Program    
  More Information


University of Wisconsin Memory Research Program  This link exits the ClinicalTrials.gov site
 

Publications:

Study ID Numbers:   IA0049, IRB M1285
First Received:   July 31, 2003
Last Updated:   March 23, 2006
ClinicalTrials.gov Identifier:   NCT00065767
Health Authority:   United States: Federal Government

Keywords provided by National Institute on Aging (NIA):
Alzheimer disease  
Postmenopausal women  
Hormone therapy  

Study placed in the following topic categories:
Raloxifene
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Alzheimer Disease
Central Nervous System Diseases
Neurodegenerative Diseases
Brain Diseases
Dementia
Cognition Disorders
Delirium

Additional relevant MeSH terms:
Estrogen Receptor Modulators
Estrogen Antagonists
Hormone Antagonists
Physiological Effects of Drugs
Nervous System Diseases
Hormones, Hormone Substitutes, and Hormone Antagonists
Bone Density Conservation Agents
Selective Estrogen Receptor Modulators
Tauopathies
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 17, 2008




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