Clinical trial NCT00000176: Alzheimer's Disease Prevention 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Alzheimer Disease
Memory Disorders
Keywords: Alzheimer's disease
memory loss
Estrogen
Lead sponsor: National Institute on Aging (NIA)
Sponsor class: NIH
First posted: 1999-11-01
Sex: FEMALE
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama
state: Alabama
city: Irvine
country: United States
facility: University of California, Irvine
state: California
city: Stamford
country: United States
facility: New England Center for Headache
state: Connecticut
city: Washington
country: United States
facility: Howard University
state: District of Columbia
city: Fort Myers
country: United States
facility: Lee Memorial Health System
state: Florida
city: Jacksonville
country: United States
facility: Mayo Clinic Jacksonville
state: Florida
city: Miami Beach
country: United States
facility: Wein Center
state: Florida
city: Pensacola
country: United States
facility: West Florida Regional Medical Center
state: Florida
city: Pompano Beach
country: United States
facility: North Broward Medical Center
state: Florida
city: Tallahassee
country: United States
facility: Tallahassee Memorial Health Center
state: Florida
city: West Palm Beach
country: United States
facility: St. Mary's Medical Center
state: Florida
city: Baltimore
country: United States
facility: Johns Hopkins Bayview Medical Center
state: Maryland
city: Ridgewood
country: United States
facility: Neurology Group of Bergen County
state: New Jersey
city: New York
country: United States
facility: Columbia University
state: New York
city: New York
country: United States
facility: Cornell Medical Center, New York Presbyterian Medical Center
state: New York
city: Port Chester
country: United States
facility: New York United Hospital Medical Center
state: New York
city: White Plains
country: United States
facility: Burke Medical Research Institute
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Tulsa
country: United States
facility: Clinical Pharmaceutical Trials
state: Oklahoma
city: Providence
country: United States
facility: Butler Hospital, Rhode Island Hospital
state: Rhode Island
city: North Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Norfolk
country: United States
facility: Eastern Virginia Medical School
state: Virginia
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Mary Sano, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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. doi: 10.1016/S0140-6736(96)03356-9.
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. doi: 10.1212/wnl.48.6.1517.
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. doi: 10.1212/wnl.50.2.368.
citation: 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.