Drugs & Aging

, Volume 23, Issue 1, pp 83–92

A Substudy Protocol of the Hypertension in the Very Elderly Trial Assessing Cognitive Decline and Dementia Incidence (HYVET-COG)

An Ongoing Randomised, Double-Blind, Placebo-Controlled Trial
  • Ruth Peters
  • Nigel Beckett
  • Maria Nunes
  • Astrid Fletcher
  • Françoise Forette
  • Christopher Bulpitt
Original Research Article

DOI: 10.2165/00002512-200623010-00008

Cite this article as:
Peters, R., Beckett, N., Nunes, M. et al. Drugs Aging (2006) 23: 83. doi:10.2165/00002512-200623010-00008

Abstract

Background and objective

Randomised, controlled trials and population studies have suggested a link between hypertension and the development of dementia (vascular dementia and Alzheimer’s disease) although the results are not conclusive. The very elderly are at highest risk for both hypertension and dementia but have been underrepresented in studies to date. The Hypertension in the Very Elderly Trial (HYVET), an international, randomised, double-blind, placebo-controlled trial of antihypertensive medication for those ≥80 years of age, is currently underway. The protocol for the assessment of cognitive decline and detection of incident dementia cases is described in this article. The objective of this protocol is to determine whether treatment of hypertension in this very elderly group affects the incidence of dementia and decline in cognitive function during the period of the HYVET trial.

Methods

Cognitive function in all HYVET trial participants is assessed at baseline and annually thereafter using the Mini-Mental State Examination (MMSE). An MMSE score that decreases more than three points per year or decreases to <24 prompts further investigation for possible incident dementia. This includes use of the Diagnostic and Statistical Manual-IV criteria, the modified Hachinski scale and CT scanning. In cases where a CT scan cannot be obtained the full Hachinski scale is used. Additional information is provided when available from the clock drawing test and Geriatric Depression Scale. Data are also gathered from all trial participants with regard to education, blood pressure, alcohol use, co-morbidities and concomitant treatments.

At the end of the trial, changes in cognitive function and incident dementia cases will be compared in those receiving active treatment (indapamide slow-release ± perindopril) and those receiving matching placebo.

Results

The protocol has been applied successfully and the data collection phase is underway.

Discussion

Previous population studies have been unable to study antihyperten-sive use in a controlled manner and randomised, controlled trials suggest a positive or mixed picture regarding an association between use of antihyperten-sive therapy and reduction in incident cognitive decline and/or dementia. No such trial has yet been performed exclusively in subjects ≥80 years of age with hypertension. The HYVET trial is placebo controlled and while investigating the cardiovascular effect of treatment also assesses cognitive function and quality of life in both the placebo and actively treated arms of the trial. The HYVET cognitive substudy trial (HYVET-COG) design has been successfully applied and the instruments chosen appear to be appropriate, valid and pragmatic.

Conclusion

HYVET-COG provides the first opportunity to examine the effect of antihypertensive treatment on incident dementia in a high-risk very elderly population.

Copyright information

© Adis Data Information BV 2006

Authors and Affiliations

  • Ruth Peters
    • 1
  • Nigel Beckett
    • 1
  • Maria Nunes
    • 1
  • Astrid Fletcher
    • 2
  • Françoise Forette
    • 3
  • Christopher Bulpitt
    • 1
  1. 1.Imperial College School of Medicine, Section of Elderly CareHammersmith HospitalLondonUK
  2. 2.Department of Epidemiology and Population HealthLondon School of Hygiene and Tropical MedicineLondonUK
  3. 3.Hôpital Broca, Centre de GerontologieNational Foundation of GerontologyParisFrance