Condition category
Mental and Behavioural Disorders
Date applied
18/11/2005
Date assigned
14/12/2005
Last edited
21/09/2007
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 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

Publication citations

Additional files

Editorial Notes