Cognitive and Neurophysiological Effects of Raloxifene in Alzheimer's Disease

NCT ID: NCT00065767

Last Updated: 2015-10-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-09-30
• Study Completion Date: 2005-03-31

Brief Summary

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.

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.

Conditions

Alzheimer Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

Raloxifene

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 55 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

University of Wisconsin, Madison

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sanjay Asthana, MD

Role: PRINCIPAL_INVESTIGATOR

William S. Middleton VA Hospital, University of Wisconsin Memory Research Program

Locations

University of Wisconsin Memory Research Program

Madison, Wisconsin, United States

Countries

United States

References

Birge SJ, McEwen BS, Wise PM. Effects of estrogen deficiency on brain function. Implications for the treatment of postmenopausal women. Postgrad Med. 2001 Mar;Spec No:11-6.

Reference Type: BACKGROUND

PMID: 11296734 (View on PubMed)

Zec RF, Trivedi MA. The effects of estrogen replacement therapy on neuropsychological functioning in postmenopausal women with and without dementia: a critical and theoretical review. Neuropsychol Rev. 2002 Jun;12(2):65-109. doi: 10.1023/a:1016880127635.

Reference Type: BACKGROUND

PMID: 12371603 (View on PubMed)

Yaffe K. Estrogens, selective estrogen receptor modulators, and dementia: what is the evidence? Ann N Y Acad Sci. 2001 Dec;949:215-22. doi: 10.1111/j.1749-6632.2001.tb04024.x.

Reference Type: BACKGROUND

PMID: 11795356 (View on PubMed)

Other Identifiers

1R01AG029624-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB M1285

Identifier Type: -

Identifier Source: secondary_id

IA0049

Identifier Type: -

Identifier Source: org_study_id