N/A
N=42
Cerebral Haemodynamic Changes During Cognitive Testing: A fTCD Study
Mild Cognitive Impairment · Alzheimer Disease · Vascular Dementia · Healthy Controls
Bottom Line
View on ClinicalTrials.gov: NCT03134963 ↗Enrolled (actual)
42
Serious AEs
0.0%
Results posted
Nov 2020
Primary outcome: Primary: Percentage of Recruited Subjects Able to Comply With the Protocol — 12; 13; 3; 14 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Transcranial doppler ultrasonography (Other); Blood pressure monitoring (Other); Heart rate monitoring (Other); End tidal CO2 monitoring (Other); Addenbrooke's cognitive examination (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Leicester
- Primary completion
- Dec 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Recruited Subjects Able to Comply With the Protocol |
12; 13; 3; 14 | — |
| SECONDARY Number of Participants With Rejected Measurements |
2; 3; 0; 4 | — |
| SECONDARY Number of Participants in Which Percentage Change in CBFv Can be Derived |
10; 10; 3; 10 | — |
| SECONDARY Number of Participants in Which the Change in the Autoregulation Index (ARI) Can be Derived |
10; 10; 3; 10 | — |
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%). 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:
1. Healthy older adults
2. Patients with mild cognitive impairment (MCI)
3. Patients with vascular dementia
4. Patients with Alzheimer's dementia
Eligibility Criteria
Inclusion Criteria
- 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
- 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.
Exclusion Criteria
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT03134963). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.