A randomised placebo-controlled trial of the effect of hormone replacement therapy on dementia and cognitive function in post-menopausal women

• Register: ISRCTN
• Last refreshed on: 13 January 2015
• Main ID: ISRCTN55999335
• Date of registration: 25/10/2000
• Prospective Registration: No
• Primary sponsor: Medical Research Council (MRC) (UK)
• Public title: A randomised placebo-controlled trial of the effect of hormone replacement therapy on dementia and cognitive function in post-menopausal women
• Date of first enrolment: 01/06/2000
• Target sample size: 14240
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN55999335
• Study type: Interventional
• Study design: Randomised controlled trial (Treatment)

Countries of recruitment

United Kingdom

Contacts

• Name: Martin Prince

Key inclusion & exclusion criteria

Inclusion criteria: Age 50-69, female, post-menopausal, no contraindication to HRT.
For both components, in addition to the WISDOM trial inclusion criteria, subjects will only be recruited if they can be randomised to receive placebo, ie excluding the 21% of WISDOM recruits with a total hysterectomy who are already taking HRT.
For the dementia component sub-study only those who will reach the age of 65 years before the end of the projected follow-up period (2009) will be included.
Exclusion criteria: Not provided at time of registration

Age minimum:
Age maximum:
Gender: Female

Health Condition(s) or Problem(s) studied

Obstetrics and gynaecology
Urological and Genital Diseases
Post-menopause

Intervention(s)

Women who have had a hysterectomy and are not already taking HRT will be randomised to oestrogen only replacement therapy (ORT), progestogen and oestrogen replacement therapy (PORT) or placebo.
Women who have not had a hysterectomy will be randomised to PORT or placebo.
The principal comparison on the principal endpoints will be HRT (PORT or ORT) versus placebo.

Updated 08/07/2013: The trial was stopped around one year after recruitment began because the very similar Women's Health Initiative trial in the USA was stopped because of a higher risk of cardiovascular events and dementia in those randomised to HRT.

Primary Outcome(s)

Dementia component: The principal outcome will be onset of dementia according to ICD-10 criteria.

Cognitive component: Change of cognitive test performance on the Wechsler Logical Memory Recall.
The trial will have 90% power, at the 5% significance level, to detect an effect size, associated with randomisation to HRT, of 0.5 or greater enabling us to detect a difference of two story components recalled out of a total of 25 for Wechsler Logical Memory story recall.

Added 19/08/09: Follow up duration for primary endpoints Dementia component - 2009 (10 years) Cognitive component - Five years

Secondary Outcome(s)

Dementia component: The secondary outcome will be onset of the dementia sub-type diagnosis of Alzheimer's disease (AD) diagnosed according to NINCDS-ADRDA criteria (possible and probable).

Secondary ID(s)

G9828540

Source(s) of Monetary Support

Medical Research Council (MRC) (UK)