Neurocognitive DisordersTAHOCNCT05845736
The Impact of Dementia and Neurocognitive Disorders on Hypertension Treatment in the Elderly
An observational study of Neurocognitive Disorders and Dementia, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
Neurocognitive disorders and hypertension occur commonly with aging. While, by definition, older adults are at high cardiovascular risk, there is no guideline exist currently on blood pressure management of elderly hypertension. Read more about this study
- Who is it for?
- Ages 80 years and older
- Conditions the study is for
- Neurocognitive Disorders, Dementia, Hypertension
- What is being tested?
- Antihypertensive Agents
- How many people
- 353 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2022to 12 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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: All patients aged 80 years or more and hypertensive who received a Comprehensive Geriatric Assessment (including a mini mental state examination) as part of a frailty, memory or oncogeriatric assessment, in day hospital in the geriatric department in University Hospital of Nancy in 2022.
Who may be able to join
- to be 80 years of age
- with history of hypertension and/or on hypertensive drug(s)
Who cannot join
- legal protection measure.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of Dementia and Neurocognitive Disorders on Hypertension Treatment in the Very Elderly: the TAHOC Study
Neurocognitive disorders and hypertension occur commonly with aging. While, by definition, older adults are at high cardiovascular risk, there is no guideline exist currently on blood pressure management of elderly hypertension. However, studies have shown that in aging adults, high blood pressure helps prevent against cognitive decline, and low blood pressure on antihypertensive drugs could accelerate it. This study aims at investigating if pharmacological treatment of hypertension in the very elderly is influenced by presence and severity of neurocognitive disorders. Our research hypothesis is that the drug management of hypertension in patients 80 years of age or older more is all the less aggressive as the neurocognitive disorders are advanced.
- Conditions
- Neurocognitive Disorders, Dementia, Hypertension, Aged, 80 and Over
- Being tested
- Antihypertensive Agents
- Keywords
- Neurocognitive Disorders, Dementia, Hypertension, Aged, 80 and over
- Medical subject headings
- Neurocognitive Disorders, Dementia, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antihypertensive AgentsDrug
number of hypertensive drugs
| Study group | Role | What they receive |
|---|---|---|
| control group | absence of neurocognitive disorder (ND), Mini-Mental State Examination (MMSE) from 27 to 30 inclusive Receives: Drug: Antihypertensive Agents | |
| mild neurocognitive disorder | MMSE from 21 to 26 inclusive Receives: Drug: Antihypertensive Agents | |
| moderate neurocognitive disorder | MMSE from 11 to 20 inclusive Receives: Drug: Antihypertensive Agents | |
| severe neurocognitive disorder | MMSE less than or equal to 10 Receives: Drug: Antihypertensive Agents |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of antihypertensive agents
among ACEI/ARB2, calcium channel blocker, thiazides and related, central antihypertensive beta blocker
Measured: during inclusion
Secondary outcomes (3)
class of antihypertensive medications
among ACEI/ARB2, calcium channel blocker, thiazides and related, central antihypertensive beta blocker
Measured: during inclusion
systolic and diastolic blood pressure
blood pressure measured with upper arm cuffs
Measured: during inclusion
orthostatic hypotension
a systolic blood pressure decrease of at least 20 mm Hg or a diastolic blood pressure decrease of at least 10 mm Hg within three minutes of standing
Measured: during inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start1 Jan 2022
- Primary completion1 Jan 2022
- Study completion12 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurocognitive DisordersStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 353 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pr Athanase BENETOS, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05845736
- Sponsor's protocol ID
- 2023PI017
- Acronym
- TAHOC
- Status last verified
- May 2023
- First submitted
- 26 Mar 2023
- Last updated
- 6 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Dementia and Neurocognitive Disorders on Hypertension Treatment in the Very Elderly: the TAHOC Study
- ClinicalTrials.gov ID
- NCT05845736
- Acronym / sponsor ID
- TAHOC / 2023PI017
- Conditions
- Neurocognitive Disorders, Dementia, Hypertension, Aged, 80 and Over
- Keywords
- Neurocognitive Disorders, Dementia, Hypertension, Aged, 80 and over
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 353 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Jan 2022 (actual)
- Study completion
- 12 Dec 2022 (actual)
- First posted
- 6 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Neurocognitive disorders and hypertension occur commonly with aging. While, by definition, older adults are at high cardiovascular risk, there is no guideline exist currently on blood pressure management of elderly hypertension. However, studies have shown that in aging adults, high blood pressure helps prevent against cognitive decline, and low blood pressure on antihypertensive drugs could accelerate it. This study aims at investigating if pharmacological treatment of hypertension in the very elderly is influenced by presence and severity of neurocognitive disorders. Our research hypothesis is that the drug management of hypertension in patients 80 years of age or older more is all the less aggressive as the neurocognitive disorders are advanced.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| control group | – | Drug: Antihypertensive Agentsabsence of neurocognitive disorder (ND), Mini-Mental State Examination (MMSE) from 27 to 30 inclusive |
| mild neurocognitive disorder | – | Drug: Antihypertensive AgentsMMSE from 21 to 26 inclusive |
| moderate neurocognitive disorder | – | Drug: Antihypertensive AgentsMMSE from 11 to 20 inclusive |
| severe neurocognitive disorder | – | Drug: Antihypertensive AgentsMMSE less than or equal to 10 |
Who may qualify
- Ages
- 80 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- All patients aged 80 years or more and hypertensive who received a Comprehensive Geriatric Assessment (including a mini mental state examination) as part of a frailty, memory or oncogeriatric assessment, in day hospital in the geriatric department in University Hospital of Nancy in 2022.
Key inclusion criteria (2 listed)
- to be 80 years of age
- with history of hypertension and/or on hypertensive drug(s)
Key exclusion criteria (1 listed)
- legal protection measure.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Antihypertensive Agentsnumber of hypertensive drugs | Drug | control group, mild neurocognitive disorder, moderate neurocognitive disorder, severe neurocognitive disorder |
Primary outcome
number of antihypertensive agents
Time frame: during inclusion
among ACEI/ARB2, calcium channel blocker, thiazides and related, central antihypertensive beta blocker
3 secondary outcomes
class of antihypertensive medications
Time frame: during inclusion
systolic and diastolic blood pressure
Time frame: during inclusion
orthostatic hypotension
Time frame: during inclusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2023.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neurocognitive Disorders and Dementia, run by Central Hospital, Nancy, France at 1 site in France.
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 2 inclusion and 1 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 6 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
number of antihypertensive agents (time frame: during inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 May 2023.