Alzheimer's Disease Prevention Trial

Alzheimer Disease Clinical Trial

Official title:

Alzheimer's Disease Prevention Trial. A Multi-center, Randomized, Double-blind Placebo Controlled Trial of Estrogens to Prevent Alzheimer's Disease and Loss of Memory in Women.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00000176
• Other study ID #: IA0018
• Secondary ID: RO 1AG15922-01
• Status: Completed
• Phase: Phase 3
• First received: October 29, 1999
• Last updated: November 3, 2010
• Est. completion date: September 2007

Study information

• Verified date: November 2010
• Source: National Institute on Aging (NIA)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

This is a three-year study to determine if estrogens can prevent memory loss and Alzheimer's disease in women with a family history of Alzheimer's disease.

Description:

PREventing Postmenopausal memory loss and Alzheimer's with Replacement Estrogens (PREPARE) is a double-blind-placebo controlled trial to determine whether estrogen (or estrogen and progesterone) can delay the onset of memory loss or Alzheimer's Disease in elderly women with a family history of the disease.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: September 2007
• Est. primary completion date: September 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• Healthy women 65 or older with a family history of memory problems not currently on estrogen.

Exclusion Criteria:

• Significant neurological impairment

• Current estrogen use

• History of breast cancer

Study Design

Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Alzheimer Disease
• Memory Disorders

Intervention

Drug:
• Estrogen

• Estrogen and Progesterone

Locations

Country	Name	City	State
United States	Johns Hopkins Bayview Medical Center	Baltimore	Maryland
United States	University of Alabama	Birmingham	Alabama
United States	Duke University Medical Center	Durham	North Carolina
United States	Lee Memorial Health System	Fort Myers	Florida
United States	University of California, Irvine	Irvine	California
United States	Mayo Clinic Jacksonville	Jacksonville	Florida
United States	Wein Center	Miami Beach	Florida
United States	Columbia University	New York	New York
United States	Cornell Medical Center, New York Presbyterian Medical Center	New York	New York
United States	Eastern Virginia Medical School	Norfolk	Virginia
United States	Medical University of South Carolina	North Charleston	South Carolina
United States	West Florida Regional Medical Center	Pensacola	Florida
United States	North Broward Medical Center	Pompano Beach	Florida
United States	New York United Hospital Medical Center	Port Chester	New York
United States	Butler Hospital, Rhode Island Hospital	Providence	Rhode Island
United States	Neurology Group of Bergen County	Ridgewood	New Jersey
United States	New England Center for Headache	Stamford	Connecticut
United States	Tallahassee Memorial Health Center	Tallahassee	Florida
United States	Clinical Pharmaceutical Trials	Tulsa	Oklahoma
United States	Howard University	Washington	District of Columbia
United States	St. Mary's Medical Center	West Palm Beach	Florida
United States	Burke Medical Research Institute	White Plains	New York

Sponsors (1)

Lead Sponsor	Collaborator
National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

References & Publications (4)

Aloysi A, Van Dyk K, Sano M. Women's cognitive and affective health and neuropsychiatry. Mt Sinai J Med. 2006 Nov;73(7):967-75. Review. — View Citation

Jacobs DM, Tang MX, Stern Y, Sano M, Marder K, Bell KL, Schofield P, Dooneief G, Gurland B, Mayeux R. Cognitive function in nondemented older women who took estrogen after menopause. Neurology. 1998 Feb;50(2):368-73. — View Citation

Kawas C, Resnick S, Morrison A, Brookmeyer R, Corrada M, Zonderman A, Bacal C, Lingle DD, Metter E. A prospective study of estrogen replacement therapy and the risk of developing Alzheimer's disease: the Baltimore Longitudinal Study of Aging. Neurology. 1997 Jun;48(6):1517-21. Erratum in: Neurology 1998 Aug;51(2):654. — View Citation

Tang MX, Jacobs D, Stern Y, Marder K, Schofield P, Gurland B, Andrews H, Mayeux R. Effect of oestrogen during menopause on risk and age at onset of Alzheimer's disease. Lancet. 1996 Aug 17;348(9025):429-32. — View Citation