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ISRCTN
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ISRCTN44726453
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ClinicalTrials.gov identifier
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Public title
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Oestrogen trial to delay the onset of memory impairment
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Scientific title
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A randomised double-blind trial of the effects of hormone therapy on delayed verbal recall in older women
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Acronym
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N/A
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Serial number at source
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MCT-15222
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Study hypothesis
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To examine the effectiveness of hormone replacement therapy (HRT) in memory-impaired women at risk for probable Alzheimer's disease (AD).
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Lay summary
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Ethics approval
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Sunnybrook and Women's College Health Sciences Centre Research Ethics Board (REB) approved on the 26th June 2003
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Study design
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Randomised controlled trial
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Countries of recruitment
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Canada
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Disease/condition/study domain
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Alzheimer’s disease (AD)
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Participants - inclusion criteria
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1. History of myocardial infarction, bypass surgery, angioplasty or unstable angina for more than one year
2. Admitted after approval from family physician
3. Non-demented memo-impaired women who are at a greater than or equal to 50% probability of developing AD
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Participants - exclusion criteria
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1. Diagnosis of a dementing disorder, including AD
2. History of any conditions that might affect cognitive functioning, e.g., chronic alcohol or drug abuse, stroke, hypoxia, intracranial mass lesions, psychoses, brain trauma, or other neurological diseases
3. A medical condition with a probable prognosis of death less than two years or any unstable medical condition, including active hepatic dysfunction or disease
4. Conditions that might be exacerbated by oestrogen, including history of breast cancer, endometrial cancer, abnormal mammogram, abnormal pelvic ultrasound
5. Congestive heart failure (New York Heart Association [NYHA] Class III and IV)
6. History of myocardial infarction, bypass surgery, angioplasty or unstable angina within the past year
7. Current or history of thromboembolic event
8. Use of donepezil, galantamine, rivastigmine or hydergine less than two weeks before initiation of oestrogen therapy
9. Past use of any mode or dose of hormone replacement therapy for duration longer than half the period of time that it was used
10. 0.50 probability of developing AD in two years based on performance on the API
11. Less than 60 years of age
12. Not fluent in English
13. Perception: can’t read normal print with or with out glasses or can’t hear normal speech with or with out hearing aid
14. Current use of selective oestrogen receptor modulators
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Anticipated start date
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01/01/1998
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Anticipated end date
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30/04/2006
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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146
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Interventions
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Oestradiol and norethindrone versus placebo.
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Primary outcome measure(s)
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1. Alzheimer Disease Assessment Scale - cognitive subtest (ADAS-COG) at 1 and 2 years
2. % of cases with emergent Alzheimer's disease
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Secondary outcome measure(s)
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1. Pharmacoeconomic analysis
2. Quality of life
3. Neuropsychological test performance
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Sources of funding
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1. Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-15222)
2. Shire Biochem Inc. (Canada)
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Trial website
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Publications
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2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19297102
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Contact name
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Dr
Mary Catherine
Tierney
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Address
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A145 Geriatric Research Unit
2075 Bayview Avenue
Sunnybrook & Women's College HS Centre
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City/town
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Toronto, Ontario
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Zip/Postcode
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M4N 3M5
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Country
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Canada
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Sponsor
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Sunnybrook and Women's College Health Sciences Centre (Canada)
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Address
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University of Toronto
2075 Bayview Avenue
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City/town
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Toronto
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Zip/Postcode
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M4N 3M5
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Country
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Canada
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Sponsor website:
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http://www.sunnybrook.ca/
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Date applied
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01/09/2005
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Last edited
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08/05/2009
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Date ISRCTN assigned
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01/09/2005
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