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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01868165
Enrollment
337
Registered
2013-06-04
Start date
2013-06-30
Completion date
2016-02-29
Last updated
2019-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cognitive Ability, General, High Blood Pressure

Keywords

Cognitive decline, High blood pressure, Hypertension, Ageing, Dementia, Antihypertensives

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.

Interventions

None listed

Sponsors

Imperial College London
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
80 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Change in Cognitive Function as Measured Using the Extended Mini Mental State Exam12 monthsThe 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)

Countries

United Kingdom

Participant flow

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.

Participants by arm

ArmCount
Older Adult Cohort
Older adults receiving treatment with antihypertensive medication
292
Total292

Withdrawals & dropouts

PeriodReasonFG000
Overall StudyDeath4
Overall StudyLost to Follow-up3
Overall StudyPhysician Decision2
Overall StudyWithdrawal by Subject36

Baseline characteristics

CharacteristicOlder Adult Cohort
Age, Continuous83.5 years
STANDARD_DEVIATION 2.8
Body Mass Index27.5 kg/m^2
STANDARD_DEVIATION 4.5
Cardiovascular disease81 Participants
Diastolic blood pressure74.8 mmHg
STANDARD_DEVIATION 9.7
Extended Mini-Mental State Exam95 units on a scale
Prescribed calcium channel blockers135 Participants
Race/Ethnicity, Customized
Asian
1 Participants
Race/Ethnicity, Customized
Black
1 Participants
Race/Ethnicity, Customized
Unspecified
2 Participants
Race/Ethnicity, Customized
White
288 Participants
Region of Enrollment
United Kingdom
292 Participants
Sex: Female, Male
Female
161 Participants
Sex: Female, Male
Male
131 Participants
Systolic blood pressure137.1 mmHg
STANDARD_DEVIATION 14.4

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 292
other
Total, other adverse events
0 / 292
serious
Total, serious adverse events
0 / 292

Outcome results

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)

Time frame: 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.

ArmMeasureValue (MEAN)
Older Adult CohortChange in Cognitive Function as Measured Using the Extended Mini Mental State Exam0.58 Change on a scale
95% CI: [-0.6, 1.77]

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026