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

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ClinicalTrials.gov Identifier: NCT01868165
Recruitment Status : Completed
First Posted : June 4, 2013
Results First Posted : September 23, 2019
Last Update Posted : September 23, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease
Cognitive Ability, General High Blood Pressure

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.

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Study Type : Observational
Actual Enrollment : 337 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Assessing the Impact of Calcium Channel Blockers on COGnitive Function in the Very Elderly (AI-COG)
Study Start Date : June 2013
Actual Primary Completion Date : February 2015
Actual Study Completion Date : February 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Calcium

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



Primary Outcome Measures :
  1. 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)



Information from the National Library of Medicine

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Ages Eligible for Study:   80 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
UK Primary care
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01868165


Locations
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United Kingdom
The Kiltearn Medical Centre
Nantwich, Cheshire, United Kingdom, CW5 5NX
Ashfields Primary Care Centre
Sandbach, Cheshire, United Kingdom, CW11 BEQ
Whitby Group Practice
Whitby, North Yorkshire, United Kingdom, YO21 1SD
South Axholme Practice
Epworth, Yorkshire, United Kingdom, DN9 1EP
Dr Moss and Partners
Harrogate, United Kingdom, HG1 5JP
Gale Farm Surgery
York, United Kingdom, YO24 3BU
Haxby Group Practice
York, United Kingdom, YO32 2LL
Sponsors and Collaborators
Imperial College London
Investigators
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Principal Investigator: Ruth Peters, PhD Imperial College London, UK
Publications of Results:
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Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT01868165    
Other Study ID Numbers: P40221
First Posted: June 4, 2013    Key Record Dates
Results First Posted: September 23, 2019
Last Update Posted: September 23, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Imperial College London:
Cognitive decline
High blood pressure
Hypertension
Ageing
Dementia
Antihypertensives
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases