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

ISRCTN	ISRCTN55070842
DOI	https://doi.org/10.1186/ISRCTN55070842
Protocol serial number	N/A
Sponsor	Institute for the Study of Aging (USA)
Funder	Institute for the Study of Aging (ISOA) (USA)

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

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

Primary study design	Interventional
Study design	Intreventional - randomised, double-blind, placebo-controlled, cross-over design.
Secondary study design	Randomised controlled trial
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
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Estradiol
Primary outcome measure(s)	1. Mini-Mental Status Exam (MMSE) 2. Alzheimer's Disease Assessment Scale (ADAS) 3. Neuropsychatric Inventory (NPI) 4. Clinicial impression based on interview (CIBIC)
Key secondary outcome measure(s)	Blood test results.
Completion date	30/07/2004

Participant type(s)	Patient
Age group	Adult
Sex	Male
Target sample size at registration	40
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

Jewish General Hospital

Montreal, PQ
H3T 1E2
Canada

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan