Oestrogen trial to delay the onset of memory impairment
| ISRCTN | ISRCTN44726453 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN44726453 |
| Protocol serial number | MCT-15222 |
| Sponsor | Sunnybrook and Women's College Health Sciences Centre (Canada) |
| Funders | Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-15222), Shire Biochem Inc. (Canada) |
- 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
Scientific
A145 Geriatric Research Unit
2075 Bayview Avenue
Sunnybrook & Women's College HS Centre
Toronto, Ontario
M4N 3M5
Canada
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | A randomised double-blind trial of the effects of hormone therapy on delayed verbal recall in older women |
| Study objectives | To 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) studied | Alzheimers disease (AD) |
| Intervention | Oestradiol and norethindrone versus placebo. |
| Intervention type | Drug |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Oestradiol, norethindrone |
| Primary outcome measure(s) |
1. Alzheimer Disease Assessment Scale - cognitive subtest (ADAS-COG) at 1 and 2 years |
| Key secondary outcome measure(s) |
1. Pharmacoeconomic analysis |
| Completion date | 30/04/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 146 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/01/1998 |
| Date of final enrolment | 30/04/2006 |
Locations
Countries of recruitment
- Canada
Study participating centre
A145 Geriatric Research Unit
Toronto, Ontario
M4N 3M5
Canada
M4N 3M5
Canada
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not 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 |
