Contact information
Type
Scientific
Primary contact
Dr Howard Chertkow
ORCID ID
Contact details
Jewish General Hospital
3755 Cote Aaint Catherine Road
Montreal
PQ
H3T 1E2
Canada
+1 514 340 8260
howard.chertkow@mcgill.ca
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Study hypothesis
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
Ethics approval received on the 16th November 2000 (ref: 99-061).
Study design
Intreventional - randomised, double-blind, placebo-controlled, cross-over design.
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
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 names
Estradiol
Primary outcome measures
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 trial start date
01/11/1999
Overall trial end date
30/07/2004
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Male
Target number of participants
40 men with mild cognitive impairment
Participant 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
Recruitment start date
01/11/1999
Recruitment end date
30/07/2004
Locations
Countries of recruitment
United States of America
Trial participating centre
Jewish General Hospital
Montreal, PQ
H3T 1E2
Canada
Sponsor information
Organisation
Institute for the Study of Aging (USA)
Sponsor details
767 Fifth Avenue
Suite 4600
New York City
NY
10153
United States of America
+1 212 572 4116
tlee@rslmgmt.com
Sponsor type
Research organisation
Website
Funders
Funder type
Charity
Funder name
Institute for the Study of Aging (ISOA) (USA)
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