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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

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Conditions Cognitive Ability, General
High Blood Pressure
Enrollment 337
Recruitment Details  
Pre-assignment Details Participants had hypertension and treatment with antihypertensives.The study examined the cognitive change in older adults taking antihypertensives with a particular focus on Calcium Channel Blockers (CCB). Cognitive function was tested at 0 & 12 months. Participation in the study had no impact on treatment.
Arm/Group Title Older Adult Cohort
Hide Arm/Group Description Older adults receiving treatment with antihypertensive medication
Period Title: Overall Study
Started 337
Completed 292
Not Completed 45
Reason Not Completed
Withdrawal by Subject             36
Physician Decision             2
Lost to Follow-up             3
Death             4
Arm/Group Title Older Adult Cohort
Hide Arm/Group Description Older adults receiving treatment with antihypertensive medication
Overall Number of Baseline Participants 292
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 292 participants
83.5  (2.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 292 participants
Female
161
  55.1%
Male
131
  44.9%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 292 participants
White
288
  98.6%
Asian
1
   0.3%
Black
1
   0.3%
Unspecified
2
   0.7%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United Kingdom Number Analyzed 292 participants
292
 100.0%
Extended Mini-Mental State Exam   [1] 
Median (Inter-Quartile Range)
Unit of measure:  Units on a scale
Number Analyzed 292 participants
95
(91 to 98)
[1]
Measure Description: The extended mini mental state exam is a widely used and validated cognitive screening tool. It is scored from 0-100 Higher values are better. A population without cognitive impairment would be expected to score near the maximum value.
Systolic blood pressure  
Mean (Standard Deviation)
Unit of measure:  mmHg
Number Analyzed 292 participants
137.1  (14.4)
Diastolic blood pressure  
Mean (Standard Deviation)
Unit of measure:  mmHg
Number Analyzed 292 participants
74.8  (9.7)
Prescribed calcium channel blockers  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 292 participants
135
  46.2%
Cardiovascular disease  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 292 participants
81
  27.7%
Body Mass Index  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 292 participants
27.5  (4.5)
1.Primary Outcome
Title Change in Cognitive Function as Measured Using the Extended Mini Mental State Exam
Hide Description 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)
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Regression analysis examining change in cognitive function in older adults taking antihypertensives, results are reported for those taking calcium channel blocker antihypertensives over one year of follow up.
Arm/Group Title Older Adult Cohort
Hide Arm/Group Description:
Older adult cohort receiving antihypertensive medication
Overall Number of Participants Analyzed 292
Mean (95% Confidence Interval)
Unit of Measure: Change on a scale
0.58
(-0.60 to 1.77)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Older Adult Cohort
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Slope
Estimated Value 0.58
Confidence Interval (2-Sided) 95%
-0.60 to 1.77
Estimation Comments

Linear regression slope and 95% confidence intervals for the association between calcium channel blocker use and cognitive change was 0.58 (-0.60:1.77).

Multiple adjustments including; age, sex, education.

Time Frame 12 month
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Older Adult Cohort
Hide Arm/Group Description Older adults receiving antihypertensive medication
All-Cause Mortality
Older Adult Cohort
Affected / at Risk (%)
Total   0/292 (0.00%) 
Hide Serious Adverse Events
Older Adult Cohort
Affected / at Risk (%)
Total   0/292 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Older Adult Cohort
Affected / at Risk (%)
Total   0/292 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr Ruth Peters
Organization: Imperial College London
Phone: 07950289662
EMail: r.peters@imperial.ac.uk
Layout table for additonal information
Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT01868165    
Other Study ID Numbers: P40221
First Submitted: May 29, 2013
First Posted: June 4, 2013
Results First Submitted: February 21, 2019
Results First Posted: September 23, 2019
Last Update Posted: September 23, 2019