Assessing the Impact of Calcium Channel Blockers on COGnitive Function in the Very Elderly (AI-COG)

Completed

• Conditions: High Blood Pressure; Cognitive Ability, General

• Registration Number: NCT01868165
• Lead Sponsor: Imperial College London

Brief 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.

Detailed 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2013-05-29
• Study First Submitted QC: 2013-05-30
• Study Start: 2013-06
• Study First Posted: 2013-06-04
• Primary Completion: 2015-02
• Study Completion: 2016-02
• Results First Submitted: 2019-02-21
• Status Verified: 2019-08
• Results First Submitted QC: 2019-08-21
• Last Update Submitted: 2019-08-21
• Results First Posted: 2019-09-23
• Last Update Posted: 2019-09-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 337

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in Cognitive Function as Measured Using the Extended Mini Mental State Exam	12 months	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)

Trial Locations

Locations (7)

Gale Farm Surgery; 🇬🇧 York, United Kingdom

Haxby Group Practice; 🇬🇧 York, United Kingdom

Whitby Group Practice; 🇬🇧 Whitby, North Yorkshire, United Kingdom

The Kiltearn Medical Centre; 🇬🇧 Nantwich, Cheshire, United Kingdom

Ashfields Primary Care Centre; 🇬🇧 Sandbach, Cheshire, United Kingdom

Dr Moss and Partners; 🇬🇧 Harrogate, United Kingdom

South Axholme Practice; 🇬🇧 Epworth, Yorkshire, United Kingdom