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Cognitive and Neurophysiological Effects of Raloxifene in Alzheimer's Disease
This study has been completed.
First Received: July 31, 2003   Last Updated: June 23, 2009   History of Changes
Sponsor: 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

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

Resource links provided by NLM:


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

Additional Information:
Publications:
Study ID Numbers: IA0049, IRB M1285
Study First Received: July 31, 2003
Last Updated: June 23, 2009
ClinicalTrials.gov Identifier: NCT00065767     History of Changes
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
Estrogen Antagonists
Hormone Antagonists
Physiological Effects of Drugs
Alzheimer Disease
Nervous System Diseases
Hormones, Hormone Substitutes, and Hormone Antagonists
Central Nervous System Diseases
Bone Density Conservation Agents
Brain Diseases
Neurodegenerative Diseases
Selective Estrogen Receptor Modulators
Pharmacologic Actions
Estrogen Receptor Modulators
Raloxifene
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Dementia
Tauopathies

ClinicalTrials.gov processed this record on November 27, 2009