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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01868165
Other study ID # P40221
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 2013
Est. completion date February 2016

Study information

Verified date August 2019
Source Imperial College London
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Older adults are at increased risk of high blood pressure and cognitive decline. High blood pressure itself also increases risk of cognitive decline. A particular type of blood pressure lowering drug (a calcium channel blocker(CCB)) may lower risk of dementia in younger adults but there is no clear evidence of it's impact in those >=80. It is important that we know whether CCB use impacts on cognitive function in this age group. This study will examine the impact of antihypertensives on change in cognitive function with a particular focus on CCBs.


Description:

This study is an observational cohort study examining cognitive change in those participants taking antihypertensives and aged 80 and over and examining cognitive change in participants taking different types of antihypertensive medication.


Recruitment information / eligibility

Status Completed
Enrollment 337
Est. completion date February 2016
Est. primary completion date February 2015
Accepts healthy volunteers No
Gender All
Age group 80 Years and older
Eligibility Inclusion Criteria:

Aged 80 and over Receiving pharmacological treatment for hypertension Mini Mental State Exam score >24 No other condition likely to limit life to less than one year or to prevent the taking of informed consent.

Exclusion Criteria:

Aged under 80 years Not receiving pharmacological treatment for hypertension Mini Mental State Exam score <25 Diagnosed with a condition likely to limit life to less than one year or to prevent the taking of informed consent.

Presence of a sensory impairment or an existing neuropsychological deficit of sufficient severity to prevent cognitive testing.

Presence of a condition that will prevent cognitive testing, registered blind, profoundly deaf, suffering from an aphasia.

Study Design


Locations

Country Name City State
United Kingdom South Axholme Practice Epworth Yorkshire
United Kingdom Dr Moss and Partners Harrogate
United Kingdom The Kiltearn Medical Centre Nantwich Cheshire
United Kingdom Ashfields Primary Care Centre Sandbach Cheshire
United Kingdom Whitby Group Practice Whitby North Yorkshire
United Kingdom Gale Farm Surgery York
United Kingdom Haxby Group Practice York

Sponsors (1)

Lead Sponsor Collaborator
Imperial College London

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

Peters R. No clear relationship between antihypertensive class and cognitive function over 12 months in a cohort study of community-dwelling adults aged 80 and over. Ther Adv Chronic Dis. 2019 Jan 31;10:2040622318820849. doi: 10.1177/2040622318820849. eCo — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Cognitive Function as Measured Using the Extended Mini Mental State Exam The change in cognitive function measured using the extended mini-mental state exam (this is an extended screening test which assesses several areas of cognitive function, the scale is from 0-100, higher scores are better, those without cognitive impairment would be expected to score close to maximum) 12 months
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