Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
MCT-15222
Study information
Scientific title
A randomised double-blind trial of the effects of hormone therapy on delayed verbal recall in older women
Acronym
Study hypothesis
To examine the effectiveness of hormone replacement therapy (HRT) in memory-impaired women at risk for probable Alzheimer's disease (AD).
Ethics approval
Sunnybrook and Women's College Health Sciences Centre Research Ethics Board (REB) approved on the 26th June 2003
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Alzheimers disease (AD)
Intervention
Oestradiol and norethindrone versus placebo.
Intervention type
Drug
Phase
Not Applicable
Drug names
Oestradiol, norethindrone
Primary outcome measures
1. Alzheimer Disease Assessment Scale - cognitive subtest (ADAS-COG) at 1 and 2 years
2. % of cases with emergent Alzheimer's disease
Secondary outcome measures
1. Pharmacoeconomic analysis
2. Quality of life
3. Neuropsychological test performance
Overall trial start date
01/01/1998
Overall trial end date
30/04/2006
Reason abandoned
Eligibility
Participant inclusion criteria
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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
146
Participant exclusion criteria
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: cant read normal print with or with out glasses or cant hear normal speech with or with out hearing aid
14. Current use of selective oestrogen receptor modulators
Recruitment start date
01/01/1998
Recruitment end date
30/04/2006
Locations
Countries of recruitment
Canada
Trial participating centre
A145 Geriatric Research Unit
Toronto, Ontario
M4N 3M5
Canada
Sponsor information
Organisation
Sunnybrook and Women's College Health Sciences Centre (Canada)
Sponsor details
University of Toronto
2075 Bayview Avenue
Toronto
M4N 3M5
Canada
Sponsor type
Not defined
Website
Funders
Funder type
Research organisation
Funder name
Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-15222)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Shire Biochem Inc. (Canada)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19297102
Publication citations
-
Results
Tierney MC, Oh P, Moineddin R, Greenblatt EM, Snow WG, Fisher RH, Iazzetta J, Hyslop PS, MacLusky NJ, A randomized double-blind trial of the effects of hormone therapy on delayed verbal recall in older women., Psychoneuroendocrinology, 2009, 34, 7, 1065-1074, doi: 10.1016/j.psyneuen.2009.02.009.