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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

Tracking Information
First Submitted Date May 29, 2013
First Posted Date June 4, 2013
Results First Submitted Date February 21, 2019
Results First Posted Date September 23, 2019
Last Update Posted Date September 23, 2019
Study Start Date June 2013
Actual Primary Completion Date February 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 21, 2019)
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)
Original Primary Outcome Measures
 (submitted: May 30, 2013)
Change in cognitive function [ Time Frame: 12 months ]
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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)
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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population UK Primary care
Condition
  • Cognitive Ability, General
  • High Blood Pressure
Intervention Not Provided
Study Groups/Cohorts Cohort of older adults taking antihypertensives
Adults aged 80 and over treated with antihypertensive drugs
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: August 21, 2019)
337
Original Estimated Enrollment
 (submitted: May 30, 2013)
350
Actual Study Completion Date February 2016
Actual Primary Completion Date February 2015   (Final data collection date for primary outcome measure)
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.

Sex/Gender
Sexes Eligible for Study: All
Ages 80 Years and older   (Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number NCT01868165
Other Study ID Numbers P40221
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Imperial College London
Study Sponsor Imperial College London
Collaborators Not Provided
Investigators
Principal Investigator: Ruth Peters, PhD Imperial College London, UK
PRS Account Imperial College London
Verification Date August 2019