Trial Outcomes & Findings for Assessing the Impact of Calcium Channel Blockers on COGnitive Function in the Very Elderly (AI-COG) (NCT NCT01868165)

NCT ID: NCT01868165

Last Updated: 2019-09-23

Results Overview

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)

• Recruitment status: COMPLETED
• Target enrollment: 337 participants
• Primary outcome timeframe: 12 months
• Results posted on: 2019-09-23

Participant Flow

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.

Participant milestones

Measure	Older Adult Cohort Older adults receiving treatment with antihypertensive medication
Overall Study STARTED	337
Overall Study COMPLETED	292
Overall Study NOT COMPLETED	45

Reasons for withdrawal

Measure	Older Adult Cohort Older adults receiving treatment with antihypertensive medication
Overall Study Withdrawal by Subject	36
Overall Study Physician Decision	2
Overall Study Lost to Follow-up	3
Overall Study Death	4

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Older Adult Cohort n=292 Participants Older adults receiving treatment with antihypertensive medication
Age, Continuous	83.5 years STANDARD_DEVIATION 2.8 • n=5 Participants
Sex: Female, Male Female	161 Participants n=5 Participants
Sex: Female, Male Male	131 Participants n=5 Participants
Race/Ethnicity, Customized White	288 Participants n=5 Participants
Race/Ethnicity, Customized Asian	1 Participants n=5 Participants
Race/Ethnicity, Customized Black	1 Participants n=5 Participants
Race/Ethnicity, Customized Unspecified	2 Participants n=5 Participants
Region of Enrollment United Kingdom	292 Participants n=5 Participants
Extended Mini-Mental State Exam	95 units on a scale n=5 Participants
Systolic blood pressure	137.1 mmHg STANDARD_DEVIATION 14.4 • n=5 Participants
Diastolic blood pressure	74.8 mmHg STANDARD_DEVIATION 9.7 • n=5 Participants
Prescribed calcium channel blockers	135 Participants n=5 Participants
Cardiovascular disease	81 Participants n=5 Participants
Body Mass Index	27.5 kg/m^2 STANDARD_DEVIATION 4.5 • n=5 Participants

PRIMARY outcome

Timeframe: 12 months

Population: 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.

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)

Outcome measures

Measure	Older Adult Cohort n=292 Participants Older adult cohort receiving antihypertensive medication
Change in Cognitive Function as Measured Using the Extended Mini Mental State Exam	0.58 Change on a scale Interval -0.6 to 1.77

Adverse Events

Older Adult Cohort

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Ruth Peters

Imperial College London

Phone: 07950289662

Email: r.peters@imperial.ac.uk

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place