Effects of estradiol on cognitive function in elderly men with mild cognitive impairment
ISRCTN | ISRCTN55070842 |
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DOI | https://doi.org/10.1186/ISRCTN55070842 |
Secondary identifying numbers | N/A |
- Submission date
- 18/11/2005
- Registration date
- 14/12/2005
- Last edited
- 21/09/2007
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Howard Chertkow
Scientific
Scientific
Jewish General Hospital
3755 Cote Aaint Catherine Road
Montreal, PQ
H3T 1E2
Canada
Phone | +1 514 340 8260 |
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howard.chertkow@mcgill.ca |
Study information
Study design | Intreventional - randomised, double-blind, placebo-controlled, cross-over design. |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Not specified |
Study type | Treatment |
Scientific title | |
Study objectives | The hypothesis was that oral micronised estradiol (1 mg once a day [QD]) taken for three months would produce symptomatic improvement in memory in men with mild cognitive impairment, as compared to placebo. |
Ethics approval(s) | Ethics approval received on the 16th November 2000 (ref: 99-061). |
Health condition(s) or problem(s) studied | Mild cognitive impairment |
Intervention | Comparing the results of participants on three months of estradiol versus three months on placebo. |
Intervention type | Drug |
Pharmaceutical study type(s) | |
Phase | Not Specified |
Drug / device / biological / vaccine name(s) | Estradiol |
Primary outcome measure | 1. Mini-Mental Status Exam (MMSE) 2. Alzheimer's Disease Assessment Scale (ADAS) 3. Neuropsychatric Inventory (NPI) 4. Clinicial impression based on interview (CIBIC) |
Secondary outcome measures | Blood test results. |
Overall study start date | 01/11/1999 |
Completion date | 30/07/2004 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Sex | Male |
Target number of participants | 40 men with mild cognitive impairment |
Key inclusion criteria | 1. Male with mild cognitive impairment (Mini-Mental State Examination [MMSE] of 26 to 30) 2. Between the ages of 55 to 98 3. Hypertension was well controlled 4. Had a caregiver |
Key exclusion criteria | 1. Carcinoma of the prostate, hypercalcaemia, metabolic diseases, severe Chronic Obstuctive Pulmonary Disease (COPD) and renal insufficiency 2. Clotting abnormality, hyper-coagulable states, sleep apnoea 3. Patients on coumadin with Deep Vein Thrombosis (DVT) (or with a known clotting disorder) and diabetes (if uncontrolled) 4. Liver disease, unstable coronary artery disease, history of cerebrovascular accident, recent classical migraines, thrombophlebitis or thromboembolic disease 5. Must not be on any other cognitive enhancing treatment. If so, must be washed-out for 30 days |
Date of first enrolment | 01/11/1999 |
Date of final enrolment | 30/07/2004 |
Locations
Countries of recruitment
- Canada
- United States of America
Study participating centre
Jewish General Hospital
Montreal, PQ
H3T 1E2
Canada
H3T 1E2
Canada
Sponsor information
Institute for the Study of Aging (USA)
Research organisation
Research organisation
767 Fifth Avenue, Suite 4600
New York City, NY
10153
United States of America
Phone | +1 212 572 4116 |
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tlee@rslmgmt.com | |
https://ror.org/049v75w11 |
Funders
Funder type
Charity
Institute for the Study of Aging (ISOA) (USA)
No information available
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |