AzTrials
AzTrials

Alzheimer DiseasePhase 2NCT00368459

Raloxifene for Women With Alzheimer's Disease

A Phase 2 study testing raloxifene in people with Alzheimer Disease, run by Stanford University at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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

Who is it for?
Ages 60 years and older, women only
Conditions the study is for
Alzheimer Disease
What is being tested?
raloxifene
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
42 participants
Where
4 sitesUnited States
Study dates
Aug 2006to Jan 2012
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 23Show fewer
  • 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
  • Effective dose of an FDA-approved cholinesterase inhibitor for at least 6 months prior to randomization (usually donepezil 5 or 10 mg/d, rivastigmine 6 to 12 mg/d, or galantamine 16 to 24 mg/d); stable effective dose for at least 2 months prior to randomization
  • No psychotropic medication within 4 weeks of study entry or stable dose (for at least 4 weeks month) of psychotropic medications
  • No experimental mediation for the treatment of cognitive impairment associated with dementia within 2 months of study entry
  • No raloxifene within 6 months of study entry
  • No systemic estrogen, progestin, testosterone, related gonadal hormone therapy within 2 months of study entry
  • No other known contraindication to raloxifene or donepezil
  • A primary caregiver who knows the participant well and who is able to accompany her for regular assessments during the course of the study
  • Assent or consent of participant plus informed consent from participant's next of kin or legally authorized representative

Who cannot join

  • 1. Failure to meet inclusion criteria

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • Indiana University Medical Center

    Indianapolis, Indiana, 46202

  • Kaiser Permanente Santa Rosa

    Santa Rosa, California, 95403

  • Southern Illinois University School of Medicine

    Springfield, Illinois, 62794

  • Stanford University School of Medicine

    Stanford, California, 94305

Other trials in United States

About this study

Official title: Raloxifene in Women With AD: Randomized Controlled Trial

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

Read the detailed description

Raloxifene , a selective estrogen receptor modulator, has attracted attention as a potential treatment for Alzheimer's disease in women, but it has not been studied in this disorder.

To assess feasibility of large-scale efficacy trials and to obtain an initial estimate of treatment effect, study investigators plan to conduct a pilot, randomized, double blind, placebo-controlled, clinical trial of high-dose (120 mg daily) raloxifene. Eligible participants are postmenopausal women with late-onset Alzheimer's disease of mild-to-moderate severity taking a stable dose of an approved cholinesterase inhibitor. This pilot study is not designed to have power to detect significant, modest between-group differences of the magnitude provided by current FDA-approved therapies.

Study participants will be randomly allocated to oral raloxifene or identical placebo over a 12 month period. Outcomes of interest will be obtained at 6 and 12 months. The prespecified primary outcome is the change in the Alzheimer's Disease Assessment Scale, cognitive subscale (ADAS-cog), compared between groups at 12 months. Prespecified secondary outcomes include measures of global severity (Clinical Dementia Rating sum of boxes), function (Activities of Daily Living), behavior (Neuropsychiatric inventory), and other neuropsychological measures. Caregiver outcomes will be burden (Zarit burden inventory) and distress (from the Neuropsychiatric inventory).

Being tested
raloxifene, Placebo
Keywords
raloxifene, women
Medical subject headings
Alzheimer Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • raloxifeneDrug

    Also called Evista

    Raloxifene is a selective estrogen receptor modulator

  • PlaceboDrug

    Also called There are no other names.

    Identical appearing placebo

Study groups in NCT00368459
Study groupRoleWhat they receive
raloxifeneExperimentaloral raloxifene 120 mg once daily
Receives: Drug: raloxifene
placeboPlacebo comparatoridentical appearing oral placebo
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 12 months

Secondary outcomes (9)

  1. Global Rating, Clinical Dementia Rating (CDR) Sum of Boxes

    Global rating of dementia severity, change from baseline at 12 months. Range 0-5. For results below, positive change represents improvement/ better performance.

    Measured: 12 months

  2. Function, Activities of Daily Living (ADL)

    ADL scale from the Alzheimer's Disease Cooperative Study, change from baseline at 12 months. Range 0-78. For results below, positive change represents improvement/ better performance.

    Measured: 12 months

  3. Behavior

    Neuropsychiatric Inventory, change from baseline at 12 months. Range 0-120. For results below, positive change represents improvement/ better performance.

    Measured: 12 months

  4. Cognitive (Neuropsychological)

    Global composite calculated as a weighted average of standardized scores of neuropsychological tests (weighted by the inverse intertest correlation matrix), change from baseline at 12 months. There is no theoretical maximum or minimum for this cognitive composite, with a score of 0 standardized units representing no change. For results below, positive change represents improvement/ better performance.

    Measured: 12 months

  5. ADAS-cog

    Change from baseline at 6 months, compared between groups. Error score range 0-70. For results below, positive change represents improvement/ better performance.

    Measured: 6 months

  6. Clinical Dementia Rating, Sum of Boxes

    Change from baseline at 6 months, compared between groups. Range 0-5. For results below, positive change represents improvement/ better performance.

    Measured: 6 months

  7. Function, Activities of Daily Living

    Change from baseline at 6 months, compared between groups. Range 0-78. For results below, positive change represents improvement/ better performance.

    Measured: 6 months

  8. Behavior

    Neuropsychiatric Inventory, change from baseline at 6 months, compared between groups. Range 0-120. For results below, positive change represents improvement/ better performance.

    Measured: 6 months

  9. Cognition (Neuropsychological)

    Global composite calculated as a weighted average of standardized scores of neuropsychological tests (weighted by the inverse intertest correlation matrix), change from baseline at 6 months. There is no theoretical maximum or minimum for this cognitive composite, with a score of 0 standardized units representing no change. For results below, positive change represents improvement/ better performance.

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Aug 2006 (estimated)
  2. Study startAug 2006
  3. Primary completionMar 2011
  4. Study completionJan 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
42 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00368459
Sponsor's protocol ID
IA0096
Status last verified
Mar 2015
First submitted
22 Aug 2006
Last updated
2 Apr 2015
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing raloxifene in people with Alzheimer Disease, run by Stanford University at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 23 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Apr 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Alzheimer's Disease Assessment Scale, Cognitive Subscale (ADAS-cog) (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00368459.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2015.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in