Cognitive Ability, GeneralNCT01868165
Assessing the Impact of Calcium Channel Blockers on COGnitive Function in the Very Elderly (AI-COG)
An observational study of Cognitive Ability, General and High Blood Pressure, run by Imperial College London at 7 sites in United Kingdom.
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… Read more about this study
- Who is it for?
- Ages 80 years and older
- Conditions the study is for
- Cognitive Ability, General, High Blood Pressure
- How many people
- 337 participants
- Where
- 7 sitesUnited Kingdom
- Study dates
- Jun 2013to Feb 2016
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 80 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: UK Primary care
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United Kingdom7 sites
South Axholme Practice
Epworth, Yorkshire, DN9 1EP
Dr Moss and Partners
Harrogate, HG1 5JP
The Kiltearn Medical Centre
Nantwich, Cheshire, CW5 5NX
Ashfields Primary Care Centre
Sandbach, Cheshire, CW11 BEQ
Whitby Group Practice
Whitby, North Yorkshire, YO21 1SD
Gale Farm Surgery
York, YO24 3BU
Haxby Group Practice
York, YO32 2LL
About this study
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.
Read the 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.
- Conditions
- Cognitive Ability, General, High Blood Pressure
- Keywords
- Cognitive decline, High blood pressure, Hypertension, Ageing, Dementia, Antihypertensives
- Medical subject headings
- Hypertension, Cognitive Dysfunction, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cohort of older adults taking antihypertensives | Adults aged 80 and over treated with antihypertensive drugs |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2013 (estimated)
- Study startJun 2013
- Primary completionFeb 2015
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cognitive Ability, GeneralStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 337 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ruth Peters, PhD, Principal investigator, Imperial College London, UK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01868165
- Sponsor's protocol ID
- P40221
- Status last verified
- Aug 2019
- First submitted
- 29 May 2013
- Last updated
- 23 Sep 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
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.
PubMed 30728929
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Impact of Calcium Channel Blockers on COGnitive Function in the Very Elderly (AI-COG)
- ClinicalTrials.gov ID
- NCT01868165
- Acronym / sponsor ID
- P40221
- Conditions
- Cognitive Ability, General, High Blood Pressure
- Keywords
- Cognitive decline, High blood pressure, Hypertension, Ageing, Dementia, Antihypertensives
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 337 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 4 Jun 2013 (estimated)
- Results
- Posted 23 Sep 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort of older adults taking antihypertensives | – | –Adults aged 80 and over treated with antihypertensive drugs |
Who may qualify
- Ages
- 80 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- UK Primary care
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 30728929Peters 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.
- Individual participant dataSharing planned: No
Related trials for Cognitive Ability, General
Not yet recruiting
Thrive at Home: A Virtual Reality Social Intervention for Older Adults
Mental Health (Depression), Mental Health and General Well-being
Not yet recruiting
EFFET - Study of Executive Functions Regarding the Usability and User Experience of Assistive Technologies Among the Elderly
Gerontology, Cognitive Ability General
RecruitingObservational study
Cognitive Functioning in Adults With Somatic Diseases and General Population From a Biopsychosocial Perspective
Aphasia, Development, Human
RecruitingObservational study
Automated IADL Sensing to Refine Measurement of Older Adult Daily Activity
Cognitive Ability General, Functional Abilities
Recruiting
Effect of Sage Extract Supplementation on Cognitive Function in Middle-Aged Men and Women
Cognitive Ability, General
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ruth Peters, PhD principal investigator
Imperial College London, UK
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cognitive Ability, General and High Blood Pressure, run by Imperial College London at 7 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Sep 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Cognitive Function as Measured Using the Extended Mini Mental State Exam (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01868165, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2019.