Alzheimer?s disease (AD) Nervous System Diseases Alzheimer?s disease
Conditions
Interventions
Oestradiol and norethindrone versus placebo.
Sponsors
Sunnybrook and Women's College Health Sciences Centre (Canada)
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
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: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Alzheimer Disease Assessment Scale - cognitive subtest (ADAS-COG) at 1 and 2 years 2. % of cases with emergent Alzheimer's disease | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Pharmacoeconomic analysis 2. Quality of life 3. Neuropsychological test performance | — |
Countries
Canada
Outcome results
None listed