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Cognitive and Neurophysiological Effects of Raloxifene in Alzheimer's Disease

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00065767
First Posted: August 4, 2003
Last Update Posted: October 5, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
University of Wisconsin, Madison
  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 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Cognitive and Neurophysiological Effects of Raloxifene in Alzheimer's Disease

Resource links provided by NLM:


Further study details as provided by University of Wisconsin, Madison:

Estimated Enrollment: 20
Study Start Date: September 2001
Study Completion Date: March 2005
Primary Completion Date: March 2005 (Final data collection date for primary outcome measure)
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

Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years to 90 Years   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00065767


Locations
United States, Wisconsin
University of Wisconsin Memory Research Program
Madison, Wisconsin, United States, 53705
Sponsors and Collaborators
University of Wisconsin, Madison
National Institute on Aging (NIA)
Investigators
Principal Investigator: Sanjay Asthana, MD William S. Middleton VA Hospital, University of Wisconsin Memory Research Program
  More Information

Publications:
Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT00065767     History of Changes
Other Study ID Numbers: IA0049
1R01AG029624-01 ( U.S. NIH Grant/Contract )
IRB M1285
First Submitted: July 31, 2003
First Posted: August 4, 2003
Last Update Posted: October 5, 2015
Last Verified: September 2010

Keywords provided by University of Wisconsin, Madison:
Alzheimer disease
Postmenopausal women
Hormone therapy

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