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

August 21, 2019 updated by: Imperial College London
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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

337

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Harrogate, United Kingdom, HG1 5JP
        • Dr Moss and Partners
      • York, United Kingdom, YO24 3BU
        • Gale Farm Surgery
      • York, United Kingdom, YO32 2LL
        • Haxby Group Practice
    • Cheshire
      • Nantwich, Cheshire, United Kingdom, CW5 5NX
        • The Kiltearn Medical Centre
      • Sandbach, Cheshire, United Kingdom, CW11 BEQ
        • Ashfields Primary Care Centre
    • North Yorkshire
      • Whitby, North Yorkshire, United Kingdom, YO21 1SD
        • Whitby Group Practice
    • Yorkshire
      • Epworth, Yorkshire, United Kingdom, DN9 1EP
        • South Axholme Practice

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

80 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

UK Primary care

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Cohort of older adults taking antihypertensives
Adults aged 80 and over treated with antihypertensive drugs

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Cognitive Function as Measured Using the Extended Mini Mental State Exam
Time Frame: 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)
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Imperial College London

Investigators

  • Principal Investigator: Ruth Peters, PhD, Imperial College London, UK

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2013

Primary Completion (Actual)

February 1, 2015

Study Completion (Actual)

February 1, 2016

Study Registration Dates

First Submitted

May 29, 2013

First Submitted That Met QC Criteria

May 30, 2013

First Posted (Estimate)

June 4, 2013

Study Record Updates

Last Update Posted (Actual)

September 23, 2019

Last Update Submitted That Met QC Criteria

August 21, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P40221

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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