Mild Cognitive ImpairmentNCT03134963
Cerebral Haemodynamic Changes During Cognitive Testing: A fTCD Study
An observational study of Mild Cognitive Impairment and Alzheimer Disease, run by University of Leicester at 2 sites in United Kingdom.
Trial summary
850,000 people live with dementia in the UK, with that number expected to rise to more than 1 million within the next 5 years. The most common type of dementia (55%) is Alzheimer's dementia, and vascular dementia is the second commonest type (15%). Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Mild Cognitive Impairment, Alzheimer Disease, Vascular Dementia
- What is being tested?
- Transcranial doppler ultrasonography, Blood pressure monitoring and Heart rate monitoring
- How many people
- 42 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 5 May 2017to 1 Dec 2017
- 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 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy controls - age, sex and co-morbidity matched. Patients with Alzheimer's dementia, vascular dementia, and mild cognitive impairment
Who may be able to join
- Informed volunteer consent, patient consent
- Male or female, aged between 18 and 100 years of age
- Able (in the Investigator's opinion) and willing to comply with all study requirements
- Willing to allow his or her General Practitioner (GP) to be notified of participation in the study
- Good understanding of written and verbal English
- Healthy Controls-specific Inclusion Criteria
Show all 33Show fewer
- No evidence of subjective or objective memory impairment on cognitive testing
- No major medical co-morbidity (outlined in detail in the exclusion criteria) or medication use that could adversely affect cognition
- MCI Patient-specific Inclusion Criteria
- Clinical diagnosis of MCI made by a specialist in a patient who fulfils the established clinical consensus criteria for MCI [NIA/AA 2011] specifically:
- Concern regarding a change in cognition compared to the person's previous level, by the patient and/or informant
- Objective evidence of impairment of one or more cognitive domains, greater than expected for age, and educational background, over time if repeated measures are available.
- Preserved independence of functional abilities and minimal to no impairment on complex instrumental functions
- Not demented
- Vascular Dementia Specific Inclusion Criteria
- Clinical diagnosis of VascD made by a specialist in a patient who fulfils the NINDS-AIREN criteria for VascD, specifically:
- Cerebrovascular disease defined by the presence of focal signs on neurological examination consistent with stroke and evidence of cerebrovascular disease on brain imaging.
- One or more of:
- Onset of dementia within 3 months of a diagnosed stroke
- Abrupt deterioration in cognitive function
- Fluctuating, stepwise progression of cognitive deficits
- Alzheimer's Dementia Specific Inclusion Criteria
- Clinical Diagnosis of AlzD made by a specialist in a patient who fulfils the NIA/AA criteria for Probable AlzD, specifically:
- Meets the criteria for dementia
- The memory impairment and cognitive deficits cause significant impairment in social or occupational functioning, and represent a significant decline from a previous level of functioning, not explained by a delirium or a major psychiatric disorder
- Impairment of at least two cognitive domains
- Insidious or gradual onset
- Clear history of worsening cognition by report or observation
- The initial and most prominent cognitive deficits are evident on history and examination in one of the following domains:
- Amnestic: impaired learning and recall of recently learned information
- Non amnestic: language/visuospatial/executive dysfunction
- No evidence of substantial cerebrovascular disease, core features of dementia with lewy bodies, features of frontotemporal dementia, prominent features of semantic variant primary progressive aphasia, evidence of active neurological disease, a non-neurological co-morbidity or medication that could affect cognition
- A specialist being defined as a psychiatrist or a geriatrician, or a specialist mental health nurse with a specific interest or expertise in cognitive disorders.
Who cannot join
- Male or Female, aged under 18 years
- Unable (in the Investigator's opinion) or unwilling to comply with any study requirements
- Female participants who are pregnant, lactating or planning pregnancy during the course of the study
- Major co-morbidity likely to affect cerebral autoregulation; severe respiratory disease, carotid artery stenosis, atrial fibrillation, severe cardiac failure (left ventricular ejection fraction <20%), extreme frailty or multi-morbidity.
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
University Hospitals of Leicester NHS Trust
Leicester, Leicestershire, LE1 5WW
Leicestershire Partnership Trust
Leicester, Leicestershire
About this study
Official title: Cerebral Haemodynamic Changes During Cognitive Testing: a Functional Transcranial Doppler (fTCD) Study
850,000 people live with dementia in the UK, with that number expected to rise to more than 1 million within the next 5 years. The most common type of dementia (55%) is Alzheimer's dementia, and vascular dementia is the second commonest type (15%). Mild cognitive impairment (MCI) affects up to 20% of older adults and describes a set of symptoms rather than a specific medical condition or disease. A person with MCI has subtle problems with one or more of the following: day-to-day memory, concentrating, planning or organising, language (eg struggling to find the right word), and judging distances and seeing objects properly. Although MCI significantly increases the risk of developing dementia (by up to 5 times), at present it is not possible to accurately predict which patients with MCI will progress to dementia. In recent times there has been an increasing awareness that problems with brain blood flow may contribute to the development, or progression, of dementia. Tests of mental abilities, with standardised questions and pen-and-paper tests are a key component of the formal diagnosis of dementia, yet little is known of the effects of these tests on brain blood flow. Brain blood flow can be can be assessed non-invasively by the use of Trans Cranial Doppler (TCD). This means using ultrasound probes over both sides of the head to measure changes in blood flow in one of the main brain arteries (the middle cerebral artery). This proposed study will therefore use TCD to evaluate changes in brain blood flow during performance of the Addenbrooke's-III (ACE-III) cognitive assessment in four key groups of patients, specifically:
- Healthy older adults
- Patients with mild cognitive impairment (MCI)
- Patients with vascular dementia
- Patients with Alzheimer's dementia
Read the detailed description
Dementia is the most common neurodegenerative disorder in the United Kingdom (UK); 850,000 people currently live with dementia in the UK, and that number is expected to rise to more than 1 million within the next 5 years. The annual cost to the UK of dementia is £23.6 billion. The most common type of dementia in the population (55%) is Alzheimer's dementia (AlzD). AlzD typically has a gradual onset and a slow progression. Vascular dementia (VascD) is the second commonest form of dementia (15%), and is suggested by the presence of vascular risk factors such as high blood pressure, high cholesterol, smoking and heart disease. The onset of vascular dementia is often abrupt, and the progression stepwise and irregular; cognitive deficits are often less uniform than those of Alzheimer's dementia. Mild cognitive impairment (MCI) affects up to 20% of older adults and describes a set of symptoms rather than a specific medical condition or disease. A person with MCI has subtle problems with one or more of the following: day-to-day memory, planning, language, attention and visuospatial skills. Although MCI significantly increases the risk of developing dementia at present it is not possible to accurately predict which patients with MCI will progress to dementia.
In recent times, our knowledge regarding the mechanisms of dementia development has changed considerably. In contrast to previous thoughts, there is now a growing understanding that problems with blood vessels (vascular dysfunction) and brain blood flow (cerebral haemodynamics) are present in AlzD as well as in VascD. Research studies investigating the vascular contributions to dementia generally report low blood flow (cerebral hypoperfusion). It is thought that this hypoperfusion affects cellular health which in turn triggers neurodegenerative pathways.
Brain blood flow is directly linked to brain activity, a concept known as 'neurovascular coupling'. Brain activation can be achieved through various cognitive and visual tasks (e.g reading and writing), and also by sensorimotor tasks (e.g. movement or touch). Cognitive assessments are routinely used in the diagnosis of dementia. Brain blood flow can be studied using techniques such as functional magnetic resonance imaging (fMRI), positron emission tomography (PET) or single-photon emission computed tomography (SPECT). However, these techniques are expensive, in the case of SPECT involve radiation, and there are feasibility issues which are particularly problematic for older populations, including the need to lie still for prolonged periods and have no metal implants. Transcranial Doppler (TCD) ultrasound is a simple, non-invasive imaging technique which allows for the continuous and bilateral recording of brain blood flow velocity through the major arteries in the brain.
Cognitive testing with standardised assessment tools such as the Mini Mental State Examination, Montreal Cognitive Assessment and Addenbrooke's-III Cognitive Examination (ACE-III) is a key component of the formal diagnosis of dementia, yet the effects of these tests on brain blood flow and haemodynamics is unknown. The ACE-III is a widely used, validated, cognitive screening tool recommended for use by health practitioners and researchers in patients over 50 years old with suspected dementia. The ACE-III is available for free. The copyright is held by Professor John Hodges, ARC Federation Fellow and Professor of Cognitive Neurology at Neuroscience Research Australia, who is happy for the test to be used in clinical practice and research projects.
This protocol has been used successfully by this group to examine changes in CBFv in 40 healthy volunteers from the University of Leicester. The data from this analysis has been presented at an international conference and is currently undergoing peer review for publication. Therefore, this protocol has demonstrated feasibility in a healthy population and warrants further investigation for the utility in a patient population.
This research will therefore use transcranial Doppler ultrasound to study the brain blood flow responses of healthy controls, patients with AlzD, patients with VascD, and patients with MCI, in response to performance of the ACE-III cognitive examination.
- Being tested
- Transcranial doppler ultrasonography, Blood pressure monitoring, Heart rate monitoring, End tidal CO2 monitoring, Addenbrooke's cognitive examination
- Medical subject headings
- Cognitive Dysfunction, Alzheimer Disease, Dementia, Vascular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial doppler ultrasonographyOther
Also called TCD
Measurement of cerebral blood flow whilst undertaking cognitive tasks with TCD monitoring.
Blood pressure monitoringOther
Also called Finometer
Continuous blood pressure recording
Heart rate monitoringOther
Also called Electrocardiogram
Continuous heart rate monitoring
End tidal CO2 monitoringOther
Also called Capnography
Continuous ETCO2 monitoring
Addenbrooke's cognitive examinationOther
Also called ACE III
Performance of a memory test
| Study group | Role | What they receive |
|---|---|---|
| Mild cognitive impairment | MCI Patient-specific Inclusion Criteria
Clinical diagnosis of MCI made by a specialist* in a patient who fulfils the established clinical consensus criteria for MCI [NIA/AA 2011] specifically:
* Concern regarding a change in cognition compared to the person's previous level, by the patient and/or informant
* Objective evidence of impairment of one or more cognitive domains, greater than expected for age, and educational background, over time if repeated measures are available.
* Preserved independence of functional abilities and minimal to no impairment on complex instrumental functions
* Not demented Receives: Other: Transcranial doppler ultrasonography; Other: Blood pressure monitoring; Other: Heart rate monitoring; Other: End tidal CO2 monitoring; Other: Addenbrooke's cognitive examination | |
| Alzheimer disease | NIA/AA criteria
* Meets the criteria for dementia
o The memory impairment and cognitive deficits cause significant impairment functioning, a significant decline from a previous level of functioning, Impairment of at least two cognitive domains
* Insidious or gradual onset
* Clear history of worsening cognition by report or observation
* The initial and most prominent cognitive deficits are evident on history and examination in one of the following domains:
* Amnestic: impaired learning and recall of recently learned information
* Non amnestic: language/visuospatial/executive dysfunction Receives: Other: Transcranial doppler ultrasonography; Other: Blood pressure monitoring; Other: Heart rate monitoring; Other: End tidal CO2 monitoring; Other: Addenbrooke's cognitive examination | |
| Vascular dementia | NINDS-AIREN criteria for VascD, specifically:
* Cerebrovascular disease defined by the presence of focal signs on neurological examination consistent with stroke and evidence of cerebrovascular disease on brain imaging.
* One or more of:
* Onset of dementia within 3 months of a diagnosed stroke
* Abrupt deterioration in cognitive function
* Fluctuating, stepwise progression of cognitive deficits Receives: Other: Transcranial doppler ultrasonography; Other: Blood pressure monitoring; Other: Heart rate monitoring; Other: End tidal CO2 monitoring; Other: Addenbrooke's cognitive examination | |
| Healthy controls | Healthy Controls-specific Inclusion Criteria
1. No evidence of subjective or objective memory impairment on cognitive testing
2. No major medical co-morbidity (outlined in detail in the exclusion criteria) or medication use that could adversely affect cognition Receives: Other: Transcranial doppler ultrasonography; Other: Blood pressure monitoring; Other: Heart rate monitoring; Other: End tidal CO2 monitoring; Other: Addenbrooke's cognitive examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Recruited Subjects Able to Comply With the Protocol
The percentage of recruited subjects (HC, MCI patients, VascD patients and AlzD patients) able to comply with the full measurement protocol.
Measured: 8 months
Secondary outcomes (3)
Number of Participants With Rejected Measurements
The percentage of measurements rejected because of aspects related to data quality during the analysis protocol, with recorded reasons
Measured: 8 months
Number of Participants in Which Percentage Change in CBFv Can be Derived
Overall, the percentage of recruited subjects (healthy controls, MCI patients, VascD patients and AlzD patients) in whom values for the following parameters can be derived:
- % change of CBFv at baseline in response to performance of the ACE-III Cognitive Examination
Measured: 8 months
Number of Participants in Which the Change in the Autoregulation Index (ARI) Can be Derived
Overall, the percentage of recruited subjects (healthy controls, MCI patients, VascD patients and AlzD patients) in whom values for the following parameters can be derived:
- Autoregulation index (using the Tiecks model and from the phase, gain and coherence).
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2017
- Study start5 May 2017
- Primary completion1 Dec 2017
- Study completion1 Dec 2017
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.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Leicester
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thompson G Robinson, MD, Principal investigator, University of Leicester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03134963
- Sponsor's protocol ID
- 0613
- Status last verified
- Mar 2017
- First submitted
- 9 Mar 2017
- Last updated
- 5 Oct 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cerebral Haemodynamic Changes During Cognitive Testing: a Functional Transcranial Doppler (fTCD) Study
- ClinicalTrials.gov ID
- NCT03134963
- Acronym / sponsor ID
- 0613
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- University of LeicesterUniversity, hospital or other
- Study start
- 5 May 2017 (actual)
- Primary completion
- 1 Dec 2017 (actual)
- Study completion
- 1 Dec 2017 (actual)
- First posted
- 1 May 2017 (actual)
- Results
- Posted 25 Nov 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
850,000 people live with dementia in the UK, with that number expected to rise to more than 1 million within the next 5 years. The most common type of dementia (55%) is Alzheimer's dementia, and vascular dementia is the second commonest type (15%). Mild cognitive impairment (MCI) affects up to 20% of older adults and describes a set of symptoms rather than a specific medical condition or disease. A person with MCI has subtle problems with one or more of the following: day-to-day memory, concentrating, planning or organising, language (eg struggling to find the right word), and judging distances and seeing objects properly. Although MCI significantly increases the risk of developing dementia (by up to 5 times), at present it is not possible to accurately predict which patients with MCI will progress to dementia. In recent times there has been an increasing awareness that problems with brain blood flow may contribute to the development, or progression, of dementia. Tests of mental abilities, with standardised questions and pen-and-paper tests are a key component of the formal diagnosis of dementia, yet little is known of the effects of these tests on brain blood flow. Brain blood flow can be can be assessed non-invasively by the use of Trans Cranial Doppler (TCD). This means using ultrasound probes over both sides of the head to measure changes in blood flow in one of the main brain arteries (the middle cerebral artery). This proposed study will therefore use TCD to evaluate changes in brain blood flow during performance of the Addenbrooke's-III (ACE-III) cognitive assessment in four key groups of patients, specifically:
- Healthy older adults
- Patients with mild cognitive impairment (MCI)
- Patients with vascular dementia
- Patients with Alzheimer's dementia
Detailed description
Dementia is the most common neurodegenerative disorder in the United Kingdom (UK); 850,000 people currently live with dementia in the UK, and that number is expected to rise to more than 1 million within the next 5 years. The annual cost to the UK of dementia is £23.6 billion. The most common type of dementia in the population (55%) is Alzheimer's dementia (AlzD). AlzD typically has a gradual onset and a slow progression. Vascular dementia (VascD) is the second commonest form of dementia (15%), and is suggested by the presence of vascular risk factors such as high blood pressure, high cholesterol, smoking and heart disease. The onset of vascular dementia is often abrupt, and the progression stepwise and irregular; cognitive deficits are often less uniform than those of Alzheimer's dementia. Mild cognitive impairment (MCI) affects up to 20% of older adults and describes a set of symptoms rather than a specific medical condition or disease. A person with MCI has subtle problems with one or more of the following: day-to-day memory, planning, language, attention and visuospatial skills. Although MCI significantly increases the risk of developing dementia at present it is not possible to accurately predict which patients with MCI will progress to dementia.
In recent times, our knowledge regarding the mechanisms of dementia development has changed considerably. In contrast to previous thoughts, there is now a growing understanding that problems with blood vessels (vascular dysfunction) and brain blood flow (cerebral haemodynamics) are present in AlzD as well as in VascD. Research studies investigating the vascular contributions to dementia generally report low blood flow (cerebral hypoperfusion). It is thought that this hypoperfusion affects cellular health which in turn triggers neurodegenerative pathways.
Brain blood flow is directly linked to brain activity, a concept known as 'neurovascular coupling'. Brain activation can be achieved through various cognitive and visual tasks (e.g reading and writing), and also by sensorimotor tasks (e.g. movement or touch). Cognitive assessments are routinely used in the diagnosis of dementia. Brain blood flow can be studied using techniques such as functional magnetic resonance imaging (fMRI), positron emission tomography (PET) or single-photon emission computed tomography (SPECT). However, these techniques are expensive, in the case of SPECT involve radiation, and there are feasibility issues which are particularly problematic for older populations, including the need to lie still for prolonged periods and have no metal implants. Transcranial Doppler (TCD) ultrasound is a simple, non-invasive imaging technique which allows for the continuous and bilateral recording of brain blood flow velocity through the major arteries in the brain.
Cognitive testing with standardised assessment tools such as the Mini Mental State Examination, Montreal Cognitive Assessment and Addenbrooke's-III Cognitive Examination (ACE-III) is a key component of the formal diagnosis of dementia, yet the effects of these tests on brain blood flow and haemodynamics is unknown. The ACE-III is a widely used, validated, cognitive screening tool recommended for use by health practitioners and researchers in patients over 50 years old with suspected dementia. The ACE-III is available for free. The copyright is held by Professor John Hodges, ARC Federation Fellow and Professor of Cognitive Neurology at Neuroscience Research Australia, who is happy for the test to be used in clinical practice and research projects.
This protocol has been used successfully by this group to examine changes in CBFv in 40 healthy volunteers from the University of Leicester. The data from this analysis has been presented at an international conference and is currently undergoing peer review for publication. Therefore, this protocol has demonstrated feasibility in a healthy population and warrants further investigation for the utility in a patient population.
This research will therefore use transcranial Doppler ultrasound to study the brain blood flow responses of healthy controls, patients with AlzD, patients with VascD, and patients with MCI, in response to performance of the ACE-III cognitive examination.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Mild cognitive impairment | – | Other: Transcranial doppler ultrasonography, Other: Blood pressure monitoring, Other: Heart rate monitoring, Other: End tidal CO2 monitoring, Other: Addenbrooke's cognitive examinationMCI Patient-specific Inclusion Criteria Clinical diagnosis of MCI made by a specialist* in a patient who fulfils the established clinical consensus criteria for MCI [NIA/AA 2011] specifically: * Concern regarding a change in cognition compared to the person's previous level, by the patient and/or informant * Objective evidence of impairment of one or more cognitive domains, greater than expected for age, and educational background, over time if repeated measures are available. * Preserved independence of functional abilities and minimal to no impairment on complex instrumental functions * Not demented |
| Alzheimer disease | – | Other: Transcranial doppler ultrasonography, Other: Blood pressure monitoring, Other: Heart rate monitoring, Other: End tidal CO2 monitoring, Other: Addenbrooke's cognitive examinationNIA/AA criteria * Meets the criteria for dementia o The memory impairment and cognitive deficits cause significant impairment functioning, a significant decline from a previous level of functioning, Impairment of at least two cognitive domains * Insidious or gradual onset * Clear history of worsening cognition by report or observation * The initial and most prominent cognitive deficits are evident on history and examination in one of the following domains: * Amnestic: impaired learning and recall of recently learned information * Non amnestic: language/visuospatial/executive dysfunction |
| Vascular dementia | – | Other: Transcranial doppler ultrasonography, Other: Blood pressure monitoring, Other: Heart rate monitoring, Other: End tidal CO2 monitoring, Other: Addenbrooke's cognitive examinationNINDS-AIREN criteria for VascD, specifically: * Cerebrovascular disease defined by the presence of focal signs on neurological examination consistent with stroke and evidence of cerebrovascular disease on brain imaging. * One or more of: * Onset of dementia within 3 months of a diagnosed stroke * Abrupt deterioration in cognitive function * Fluctuating, stepwise progression of cognitive deficits |
| Healthy controls | – | Other: Transcranial doppler ultrasonography, Other: Blood pressure monitoring, Other: Heart rate monitoring, Other: End tidal CO2 monitoring, Other: Addenbrooke's cognitive examinationHealthy Controls-specific Inclusion Criteria 1. No evidence of subjective or objective memory impairment on cognitive testing 2. No major medical co-morbidity (outlined in detail in the exclusion criteria) or medication use that could adversely affect cognition |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy controls - age, sex and co-morbidity matched. Patients with Alzheimer's dementia, vascular dementia, and mild cognitive impairment
Key inclusion criteria (33 listed)
- Informed volunteer consent, patient consent
- Male or female, aged between 18 and 100 years of age
- Able (in the Investigator's opinion) and willing to comply with all study requirements
- Willing to allow his or her General Practitioner (GP) to be notified of participation in the study
- Good understanding of written and verbal English
Key exclusion criteria (4 listed)
- Male or Female, aged under 18 years
- Unable (in the Investigator's opinion) or unwilling to comply with any study requirements
- Female participants who are pregnant, lactating or planning pregnancy during the course of the study
- Major co-morbidity likely to affect cerebral autoregulation; severe respiratory disease, carotid artery stenosis, atrial fibrillation, severe cardiac failure (left ventricular ejection fraction <20%), extreme frailty or multi-morbidity.
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 |
|---|---|---|
| Transcranial doppler ultrasonographyAlso: TCDMeasurement of cerebral blood flow whilst undertaking cognitive tasks with TCD monitoring. | Other | Alzheimer disease, Healthy controls, Mild cognitive impairment, Vascular dementia |
| Blood pressure monitoringAlso: FinometerContinuous blood pressure recording | Other | Alzheimer disease, Healthy controls, Mild cognitive impairment, Vascular dementia |
| Heart rate monitoringAlso: ElectrocardiogramContinuous heart rate monitoring | Other | Alzheimer disease, Healthy controls, Mild cognitive impairment, Vascular dementia |
| End tidal CO2 monitoringAlso: CapnographyContinuous ETCO2 monitoring | Other | Alzheimer disease, Healthy controls, Mild cognitive impairment, Vascular dementia |
| Addenbrooke's cognitive examinationAlso: ACE IIIPerformance of a memory test | Other | Alzheimer disease, Healthy controls, Mild cognitive impairment, Vascular dementia |
Primary outcome
Percentage of Recruited Subjects Able to Comply With the Protocol
Time frame: 8 months
The percentage of recruited subjects (HC, MCI patients, VascD patients and AlzD patients) able to comply with the full measurement protocol.
3 secondary outcomes
Number of Participants With Rejected Measurements
Time frame: 8 months
Number of Participants in Which Percentage Change in CBFv Can be Derived
Time frame: 8 months
Number of Participants in Which the Change in the Autoregulation Index (ARI) Can be Derived
Time frame: 8 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Thompson G Robinson, MD principal investigator
University of Leicester
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mild Cognitive Impairment and Alzheimer Disease, run by University of Leicester at 2 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 33 inclusion and 4 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 5 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 25 Nov 2020). 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?
Percentage of Recruited Subjects Able to Comply With the Protocol (time frame: 8 months). 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 5 Oct 2021.