Raloxifene for Women With Alzheimer's Disease

NCT00368459 | Completed Phase 2 Results DMC

• 1 other identifier: IA0096
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 4

Brief Summary

This is a multisite pilot randomized trial of raloxifene or placebo for the treatment of women with Alzheimer's disease.

Conditions

Alzheimer Disease

Keywords

raloxifene, women

Outcome Measures

Primary Outcomes (1)

• Alzheimer's Disease Assessment Scale, Cognitive Subscale (ADAS-cog)

  ADAS-cog, change from baseline at 12 months, compared between treatment arms. The ADAS-cog is a neuropsychological battery commonly used in trials of AD patients. Error score range 0-70. For results below, positive change represents improvement/ better performance. For the primary outcome, as well as for secondary outcomes, the reported p-values reflect the calculated p-values.

  12 months

Secondary Outcomes (9)

• Global Rating, Clinical Dementia Rating (CDR) Sum of Boxes

  12 months

• Function, Activities of Daily Living (ADL)

  12 months

• Behavior

  12 months

• Cognitive (Neuropsychological)

  12 months

• ADAS-cog

  6 months

Study Arms (2)

raloxifene

EXPERIMENTAL

oral raloxifene 120 mg once daily

Drug: raloxifene

placebo

PLACEBO COMPARATOR

identical appearing oral placebo

Drug: Placebo

Interventions

raloxifene DRUG

Raloxifene is a selective estrogen receptor modulator

Also known as: Evista

raloxifene

Placebo DRUG

Identical appearing placebo

Also known as: There are no other names.

placebo

Eligibility Criteria

• Age: 60 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female
• Post menopausal
• Age at least 60 years
• Eight or more years of education with a history of premorbid literacy
• By history, fluent speaker of English
• Dementia (DSM-IV-derived criteria) present for at least six months beginning at age 60 or older
• Mild or moderate dementia, defined by Mini-Mental State examination (MMSE) score between 12 and 26, inclusive
• National Institute of Neurological and Communicative Disease and the Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria for probable Alzheimer's disease (AD) based on results of a neurologist's evaluation and laboratory tests
• Neurological history and examination within normal limits for age, except for changes consistent with AD or age
• Modified Ischemia Scale score of 4 or less
• Good physical health established by medical history, physical exam, and baseline laboratory tests
• Blood pressure \< 180/100 at time of entry
• No history of, or examination evidence for, current insulin-dependent diabetes, stroke thought to impair cognition (e.g., cortical or thalamic infarct), or other focal brain lesion or neurological disorder likely to affect cognition, or other serious medical illness likely to limit participant's ability to complete study protocol
• No history of pulmonary embolism, deep vein thrombosis, or retinal vein occlusion
• No Diagnostic and Statistical Manual (DSM) IV criteria for Major Depressive Episode or other Axis I psychiatric disorder, other than AD, within the past year

Sponsors & Collaborators

• Stanford University: lead
• Kaiser Permanente: collaborator
• Indiana University: collaborator
• Southern Illinois University: collaborator

Study Sites (4)

Kaiser Permanente Santa Rosa

Santa Rosa, California, 95403, United States

Location

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

Southern Illinois University School of Medicine

Springfield, Illinois, 62794, United States

Location

Indiana University Medical Center

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Alzheimer Disease

Interventions

Raloxifene Hydrochloride

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Tamoxifen; Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Results Point of Contact

• Title: Victor Henderson
• Organization: Stanford University

vhenderson@stanford.edu

650-723-5456

Study Officials

• Dr Victor Henderson

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 22, 2006
• First Posted: August 24, 2006
• Study Start: August 1, 2006
• Primary Completion: March 1, 2011
• Study Completion: January 1, 2012
• Last Updated: April 2, 2015
• Results First Posted: April 2, 2015

Record last verified: 2015-03

Locations

US (4)