Oestrogen trial to delay the onset of memory impairment

Completed

• Conditions: Alzheimer?s disease (AD); Nervous System Diseases; Alzheimer?s disease

• Registration Number: ISRCTN44726453
• Lead Sponsor: Sunnybrook and Women's College Health Sciences Centre (Canada)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-09-01
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 146

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Alzheimer Disease Assessment Scale - cognitive subtest (ADAS-COG) at 1 and 2 years<br>2. % of cases with emergent Alzheimer's disease

Secondary Outcome Measures

Name	Time	Method
1. Pharmacoeconomic analysis<br>2. Quality of life<br>3. Neuropsychological test performance