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Raloxifene for Women With Alzheimer's Disease

2014-07-24 14:24:04 | BioPortfolio

Summary

The purpose of this study is to determine whether Raloxifene, a selective estrogen receptor modulator (SERM), improves cognitive function in women with Alzheimer's disease.

Description

Alzheimer's disease is the most common cause of dementia, and effective treatment options remain quite limited. Raloxifene, a selective estrogen receptor modulator (SERM), is approved at lower doses for treatment and prevention of osteoporosis in postmenopausal women. Its clinical profile is well known. In laboratory studies, this compound affects brain activity in ways that might be expected to improve cognitive function, and recent clinical data support the hypothesis that a higher dose of raloxifene could improve dementia symptoms in women with Alzheimer's disease.

This is a randomized, double-blind, placebo-controlled trial of raloxifene for the treatment of women with this disorder. Eligible women must have been on a stable effective dose of a cholinesterase inhibitor for at least six months prior to randomization. An estimated 72 women with mild to moderate dementia due to Alzheimer's disease will be enrolled at two sites in this pilot study, and treatment duration will be for 12 months.

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Conditions

Alzheimer's Disease

Intervention

raloxifene, Placebo

Location

Kaiser Foundation Hospitals, Department of Neurology
Santa Rosa
California
United States
95403

Status

Recruiting

Source

Stanford University

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-24T14:24:04-0400

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Imaging correlations of tau, amyloid, metabolism, and atrophy in typical and atypical Alzheimer's disease.

Neuroimaging modalities can measure different aspects of the disease process in Alzheimer's disease, although the relationship between these modalities is unclear.

A systems-based model of Alzheimer's disease.

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Medical and Biotech [MESH] Definitions

Abnormal structures located chiefly in distal dendrites and, along with NEUROFIBRILLARY TANGLES and SENILE PLAQUES, constitute the three morphological hallmarks of ALZHEIMER DISEASE. Neuropil threads are made up of straight and paired helical filaments which consist of abnormally phosphorylated microtubule-associated tau proteins. It has been suggested that the threads have a major role in the cognitive impairment seen in Alzheimer disease.

Vaccines or candidate vaccines used to prevent or treat ALZHEIMER DISEASE.

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A carbamate-derived reversible CHOLINESTERASE INHIBITOR that is selective for the CENTRAL NERVOUS SYSTEM and is used for the treatment of DEMENTIA in ALZHEIMER DISEASE and PARKINSON DISEASE.

A biochemical phenomenon in which misfolded proteins aggregate either intra- or extracellularly. Triggered by factors such as MUTATION, POST-TRANSLATIONAL MODIFICATIONS, and environmental stress, it is generally associated with ALZHEIMER DISEASE; PARKINSON DISEASE; HUNTINGTON DISEASE; and TYPE 2 DIABETES MELLITUS.

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