Clinical trial NCT01868165: Assessing the Impact of Calcium Channel Blockers on COGnitive Function in the Very Elderly (AI-COG)
Official title: Assessing the Impact of Calcium Channel Blockers on COGnitive Function in the Very Elderly (AI-COG)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cognitive Ability, General
High Blood Pressure
Keywords: Cognitive decline
High blood pressure
Hypertension
Ageing
Dementia
Antihypertensives
Lead sponsor: Imperial College London
Sponsor class: OTHER
First posted: 2013-06-04
Enrollment: 337
Sex: ALL
Minimum age (years): 80
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: UK Primary care

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.

Eligibility 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.

Primary outcomes:
measure: Change in Cognitive Function as Measured Using the Extended Mini Mental State Exam
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Nantwich
country: United Kingdom
facility: The Kiltearn Medical Centre
state: Cheshire
city: Sandbach
country: United Kingdom
facility: Ashfields Primary Care Centre
state: Cheshire
city: Whitby
country: United Kingdom
facility: Whitby Group Practice
state: North Yorkshire
city: Epworth
country: United Kingdom
facility: South Axholme Practice
state: Yorkshire
city: Harrogate
country: United Kingdom
facility: Dr Moss and Partners
city: York
country: United Kingdom
facility: Gale Farm Surgery
city: York
country: United Kingdom
facility: Haxby Group Practice
Study officials:
affiliation: Imperial College London, UK
name: Ruth Peters, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. eCollection 2019.