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

High Blood Pressure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01868165
• Other study ID #: P40221
• Status: Completed
• 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
• 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.

Related Conditions & MeSH terms

• Cognitive Ability, General
• High Blood Pressure
• Hypertension

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