Condition category
Nervous System Diseases
Date applied
01/09/2005
Date assigned
01/09/2005
Last edited
08/05/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Mary Catherine Tierney

ORCID ID

Contact details

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

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

Alzheimer’s 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: 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

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

http://www.sunnybrook.ca/

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

  1. 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.

Additional files

Editorial Notes