Raloxifene for Women With Alzheimer's Disease - Full Text View

Sponsors and Collaborators:	National Institute on Aging (NIA) Indiana University Kaiser Permanente Stanford University Southern Illinois University
Information provided by:	National Institute on Aging (NIA)
ClinicalTrials.gov Identifier:	NCT00368459

Purpose

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.

Condition	Intervention	Phase
Alzheimer's Disease	Drug: raloxifene Drug: Placebo	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Raloxifene in Women With AD: Randomized Controlled Trial

Resource links provided by NLM:

Genetics Home Reference related topics: Alzheimer disease

MedlinePlus related topics: Alzheimer's Disease

Drug Information available for: Raloxifene hydrochloride Raloxifene

U.S. FDA Resources

Further study details as provided by National Institute on Aging (NIA):

Primary Outcome Measures:

Changes in cognitive subscale of the Alzheimer's Disease Assessment Scale [ Time Frame: at 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Changes in Clinical Dementia Rating [ Time Frame: at 6 and 12 months ] [ Designated as safety issue: No ]
Activities of Daily Living (Alzheimer's Disease Cooperative Study scale) [ Time Frame: at 6 and 12 months ] [ Designated as safety issue: No ]
Neuropsychiatric Inventory [ Time Frame: at 6 and 12 months ] [ Designated as safety issue: No ]
Cognitive subscale of the Alzheimer's Disease Assessment Scale [ Time Frame: at 3, 6, and 9 months ] [ Designated as safety issue: No ]
Other cognitive tests (East Boston Memory Test, Digit Ordering, category fluency, Trail Making Test, Boston Naming Test short version, Mini-Mental State examination, narrative writing, semantic binding) [ Time Frame: at 6 and 12 months ] [ Designated as safety issue: No ]
Caregiver burden interview [ Time Frame: at 6 and 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	72
Study Start Date:	August 2006
Estimated Study Completion Date:	July 2010
Estimated Primary Completion Date:	July 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Raloxifene	Drug: raloxifene two 60 mg tablets daily for 12 months
2: Placebo Comparator Placebo	Drug: Placebo two placebo tablets daily for 12 months

Detailed 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.

Eligibility

Ages Eligible for Study:	60 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Female, age 60+
Postmenopausal
Premorbid literacy and history of having been fluent in English
Dementia present for at least 6 months beginning at age 60+
Mild or moderate dementia (Mini-Mental State examination score 12-26, inclusive)
Probable Alzheimer's disease
Modified Ischemia Scale score of 4 or less
Good physical health established by medical history, examination, and baseline laboratory tests
Effective dose of donepezil, rivastigmine, or galantamine for at least 6 months; stable effective dose for at least 2 months
Availability of a primary caregiver who knows the participant well and who is able to accompany her for regular assessments during the course of the study

Exclusion Criteria:

Concomitant neurological disorder likely to affect cognition
Concomitant insulin-dependent diabetes or serious medical illness likely to limit the ability to complete study protocol
History of pulmonary embolism, deep vein thrombosis, or retinal vein occlusion
Major depression within past year
Experimental medication for the treatment of cognitive impairment associated with dementia within 2 months
Raloxifene within 6 months
Systemic estrogen, progestin, or testosterone within 2 months
Known contraindication to raloxifene

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00368459

Contacts

Contact: Narinder Bolaria

650-721-3308

nbolaria@stanford.edu

Locations

United States, California
Kaiser Foundation Hospitals, Department of Neurology	Recruiting
Santa Rosa, California, United States, 95403
Contact: Susan Kirk, RN 707-571-3952 Susan.Kirk@kp.org
Principal Investigator: Sue Stephenson, MD
United States, Illinois
Southern Illinois University	Recruiting
Springfield, Illinois, United States, 62794
Contact: Barbara Lokaitis 217-545-9737 blokaitis@siumed.edu
Principal Investigator: Tom Ala, MD
United States, Indiana
Indianapolis University, Department of Neurology	Recruiting
Indianapolis, Indiana, United States, 46202-5111
Contact: Sheryl Lynch 317-278-8307 slynch@iupui.edu
Contact: Julie Dickinson 317-278-4333 judickso@iupui.edu
Principal Investigator: Martin Farlow, MD

Sponsors and Collaborators

National Institute on Aging (NIA)

Indiana University

Kaiser Permanente

Stanford University

Southern Illinois University

Investigators

Principal Investigator:

Victor Henderson, MD

Stanford University

More Information

Publications:

Yaffe K, Krueger K, Cummings SR, Blackwell T, Henderson VW, Sarkar S, Ensrud K, Grady D. Effect of raloxifene on prevention of dementia and cognitive impairment in older women: the Multiple Outcomes of Raloxifene Evaluation (MORE) randomized trial. Am J Psychiatry. 2005 Apr;162(4):683-90.

Responsible Party:	Stanford University ( Dr. Victor W. Henderson )
Study ID Numbers:	IA0096, R01-AG023038
Study First Received:	August 22, 2006
Last Updated:	February 10, 2009
ClinicalTrials.gov Identifier:	NCT00368459 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Institute on Aging (NIA):

Alzheimer disease
Raloxifene
Randomized Controlled Trials
Selective Estrogen Receptor Modulators

Study placed in the following topic categories:

Estrogen Antagonists
Estrogens
Hormone Antagonists
Alzheimer Disease
Hormones, Hormone Substitutes, and Hormone Antagonists
Central Nervous System Diseases
Bone Density Conservation Agents
Brain Diseases
Neurodegenerative Diseases

Selective Estrogen Receptor Modulators
Hormones
Cognition Disorders
Estrogen Receptor Modulators
Raloxifene
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Dementia
Delirium

Additional relevant MeSH terms:

Estrogen Antagonists
Hormone Antagonists
Physiological Effects of Drugs
Alzheimer Disease
Nervous System Diseases
Hormones, Hormone Substitutes, and Hormone Antagonists
Central Nervous System Diseases
Bone Density Conservation Agents
Brain Diseases

Neurodegenerative Diseases
Selective Estrogen Receptor Modulators
Pharmacologic Actions
Estrogen Receptor Modulators
Raloxifene
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Dementia
Tauopathies

ClinicalTrials.gov processed this record on August 12, 2009