Oestrogen trial to delay the onset of memory impairment

ISRCTN ISRCTN44726453
DOI https://doi.org/10.1186/ISRCTN44726453
Secondary identifying numbers MCT-15222
Submission date
01/09/2005
Registration date
01/09/2005
Last edited
08/05/2009
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Nervous System Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Mary Catherine Tierney
Scientific

A145 Geriatric Research Unit
2075 Bayview Avenue
Sunnybrook & Women's College HS Centre
Toronto, Ontario
M4N 3M5
Canada

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific titleA randomised double-blind trial of the effects of hormone therapy on delayed verbal recall in older women
Study objectivesTo examine the effectiveness of hormone replacement therapy (HRT) in memory-impaired women at risk for probable Alzheimer's disease (AD).
Ethics approval(s)Sunnybrook and Women's College Health Sciences Centre Research Ethics Board (REB) approved on the 26th June 2003
Health condition(s) or problem(s) studiedAlzheimer’s disease (AD)
InterventionOestradiol and norethindrone versus placebo.
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Applicable
Drug / device / biological / vaccine name(s)Oestradiol, norethindrone
Primary outcome measure1. Alzheimer Disease Assessment Scale - cognitive subtest (ADAS-COG) at 1 and 2 years
2. % of cases with emergent Alzheimer's disease
Secondary outcome measures1. Pharmacoeconomic analysis
2. Quality of life
3. Neuropsychological test performance
Overall study start date01/01/1998
Completion date30/04/2006

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants146
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment01/01/1998
Date of final enrolment30/04/2006

Locations

Countries of recruitment

  • Canada

Study participating centre

A145 Geriatric Research Unit
Toronto, Ontario
M4N 3M5
Canada

Sponsor information

Sunnybrook and Women's College Health Sciences Centre (Canada)
Not defined

University of Toronto
2075 Bayview Avenue
Toronto
M4N 3M5
Canada

Website http://www.sunnybrook.ca/
ROR logo "ROR" https://ror.org/03wefcv03

Funders

Funder type

Research organisation

Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-15222)

No information available

Shire Biochem Inc. (Canada)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/08/2009 Yes No