Effects of estradiol on cognitive function in elderly men with mild cognitive impairment

ISRCTN ISRCTN55070842
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

Jewish General Hospital
3755 Cote Aaint Catherine Road
Montreal, PQ
H3T 1E2
Canada

Phone +1 514 340 8260
Email howard.chertkow@mcgill.ca

Study information

Study designIntreventional - randomised, double-blind, placebo-controlled, cross-over design.
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific title
Study objectivesThe 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) studiedMild cognitive impairment
InterventionComparing the results of participants on three months of estradiol versus three months on placebo.
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Estradiol
Primary outcome measure1. 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 measuresBlood test results.
Overall study start date01/11/1999
Completion date30/07/2004

Eligibility

Participant type(s)Patient
Age groupAdult
SexMale
Target number of participants40 men with mild cognitive impairment
Key inclusion criteria1. 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 criteria1. 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 enrolment01/11/1999
Date of final enrolment30/07/2004

Locations

Countries of recruitment

  • Canada
  • United States of America

Study participating centre

Jewish General Hospital
Montreal, PQ
H3T 1E2
Canada

Sponsor information

Institute for the Study of Aging (USA)
Research organisation

767 Fifth Avenue, Suite 4600
New York City, NY
10153
United States of America

Phone +1 212 572 4116
Email tlee@rslmgmt.com
ROR logo "ROR" 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
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan