Trial Outcomes & Findings for Cerebral Haemodynamic Changes During Cognitive Testing: A fTCD Study (NCT NCT03134963)
NCT ID: NCT03134963
Last Updated: 2021-10-05
Results Overview
The percentage of recruited subjects (HC, MCI patients, VascD patients and AlzD patients) able to comply with the full measurement protocol.
Recruitment status
COMPLETED
Target enrollment
42 participants
Primary outcome timeframe
8 months
Results posted on
2021-10-05
Participant Flow
Participant milestones
| Measure |
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
Transcranial doppler ultrasonography: Measurement of cerebral blood flow whilst undertaking cognitive tasks with TCD monitoring.
Blood pressure monitoring: Continuous blood pressure recording
Heart rate monitoring: Continuous heart rate monitoring
End tidal CO2 monitoring: Continuous ETCO2 monitoring
Addenbrooke's cognitive examination: Performance of a memory test
|
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
Transcranial doppler ultrasonography: Measurement of cerebral blood flow whilst undertaking cognitive tasks with TCD monitoring.
Blood pressure monitoring: Continuous blood pressure recording
Heart rate monitoring: Continuous heart rate monitoring
End tidal CO2 monitoring: Continuous ETCO2 monitoring
Addenbrooke's cognitive examination: Performance of a memory test
|
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
Transcranial doppler ultrasonography: Measurement of cerebral blood flow whilst undertaking cognitive tasks with TCD monitoring.
Blood pressure monitoring: Continuous blood pressure recording
Heart rate monitoring: Continuous heart rate monitoring
End tidal CO2 monitoring: Continuous ETCO2 monitoring
Addenbrooke's cognitive examination: Performance of a memory test
|
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
Transcranial doppler ultrasonography: Measurement of cerebral blood flow whilst undertaking cognitive tasks with TCD monitoring.
Blood pressure monitoring: Continuous blood pressure recording
Heart rate monitoring: Continuous heart rate monitoring
End tidal CO2 monitoring: Continuous ETCO2 monitoring
Addenbrooke's cognitive examination: Performance of a memory test
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
12
|
13
|
3
|
14
|
|
Overall Study
COMPLETED
|
12
|
13
|
3
|
14
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Cerebral Haemodynamic Changes During Cognitive Testing: A fTCD Study
Baseline characteristics by cohort
| Measure |
Mild Cognitive Impairment
n=12 Participants
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
Transcranial doppler ultrasonography: Measurement of cerebral blood flow whilst undertaking cognitive tasks with TCD monitoring.
Blood pressure monitoring: Continuous blood pressure recording
Heart rate monitoring: Continuous heart rate monitoring
End tidal CO2 monitoring: Continuous ETCO2 monitoring
Addenbrooke's cognitive examination: Performance of a memory test
|
Alzheimer Disease
n=13 Participants
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
Transcranial doppler ultrasonography: Measurement of cerebral blood flow whilst undertaking cognitive tasks with TCD monitoring.
Blood pressure monitoring: Continuous blood pressure recording
Heart rate monitoring: Continuous heart rate monitoring
End tidal CO2 monitoring: Continuous ETCO2 monitoring
Addenbrooke's cognitive examination: Performance of a memory test
|
Vascular Dementia
n=3 Participants
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
Transcranial doppler ultrasonography: Measurement of cerebral blood flow whilst undertaking cognitive tasks with TCD monitoring.
Blood pressure monitoring: Continuous blood pressure recording
Heart rate monitoring: Continuous heart rate monitoring
End tidal CO2 monitoring: Continuous ETCO2 monitoring
Addenbrooke's cognitive examination: Performance of a memory test
|
Healthy Controls
n=14 Participants
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
Transcranial doppler ultrasonography: Measurement of cerebral blood flow whilst undertaking cognitive tasks with TCD monitoring.
Blood pressure monitoring: Continuous blood pressure recording
Heart rate monitoring: Continuous heart rate monitoring
End tidal CO2 monitoring: Continuous ETCO2 monitoring
Addenbrooke's cognitive examination: Performance of a memory test
|
Total
n=42 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
72 years
n=93 Participants
|
76 years
n=4 Participants
|
83 years
n=27 Participants
|
71 years
n=483 Participants
|
73.5 years
n=36 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
4 Participants
n=483 Participants
|
10 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=93 Participants
|
10 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
10 Participants
n=483 Participants
|
32 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 Participants
n=93 Participants
|
13 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
14 Participants
n=483 Participants
|
42 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
PRIMARY outcome
Timeframe: 8 monthsThe percentage of recruited subjects (HC, MCI patients, VascD patients and AlzD patients) able to comply with the full measurement protocol.
Outcome measures
| Measure |
Mild Cognitive Impairment
n=12 Participants
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
Transcranial doppler ultrasonography: Measurement of cerebral blood flow whilst undertaking cognitive tasks with TCD monitoring.
Blood pressure monitoring: Continuous blood pressure recording
Heart rate monitoring: Continuous heart rate monitoring
End tidal CO2 monitoring: Continuous ETCO2 monitoring
Addenbrooke's cognitive examination: Performance of a memory test
|
Alzheimer Disease
n=13 Participants
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
Transcranial doppler ultrasonography: Measurement of cerebral blood flow whilst undertaking cognitive tasks with TCD monitoring.
Blood pressure monitoring: Continuous blood pressure recording
Heart rate monitoring: Continuous heart rate monitoring
End tidal CO2 monitoring: Continuous ETCO2 monitoring
Addenbrooke's cognitive examination: Performance of a memory test
|
Vascular Dementia
n=3 Participants
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
Transcranial doppler ultrasonography: Measurement of cerebral blood flow whilst undertaking cognitive tasks with TCD monitoring.
Blood pressure monitoring: Continuous blood pressure recording
Heart rate monitoring: Continuous heart rate monitoring
End tidal CO2 monitoring: Continuous ETCO2 monitoring
Addenbrooke's cognitive examination: Performance of a memory test
|
Healthy Controls
n=14 Participants
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
Transcranial doppler ultrasonography: Measurement of cerebral blood flow whilst undertaking cognitive tasks with TCD monitoring.
Blood pressure monitoring: Continuous blood pressure recording
Heart rate monitoring: Continuous heart rate monitoring
End tidal CO2 monitoring: Continuous ETCO2 monitoring
Addenbrooke's cognitive examination: Performance of a memory test
|
|---|---|---|---|---|
|
Percentage of Recruited Subjects Able to Comply With the Protocol
|
12 Participants
|
13 Participants
|
3 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: 8 monthsThe percentage of measurements rejected because of aspects related to data quality during the analysis protocol, with recorded reasons
Outcome measures
| Measure |
Mild Cognitive Impairment
n=12 Participants
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
Transcranial doppler ultrasonography: Measurement of cerebral blood flow whilst undertaking cognitive tasks with TCD monitoring.
Blood pressure monitoring: Continuous blood pressure recording
Heart rate monitoring: Continuous heart rate monitoring
End tidal CO2 monitoring: Continuous ETCO2 monitoring
Addenbrooke's cognitive examination: Performance of a memory test
|
Alzheimer Disease
n=13 Participants
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
Transcranial doppler ultrasonography: Measurement of cerebral blood flow whilst undertaking cognitive tasks with TCD monitoring.
Blood pressure monitoring: Continuous blood pressure recording
Heart rate monitoring: Continuous heart rate monitoring
End tidal CO2 monitoring: Continuous ETCO2 monitoring
Addenbrooke's cognitive examination: Performance of a memory test
|
Vascular Dementia
n=3 Participants
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
Transcranial doppler ultrasonography: Measurement of cerebral blood flow whilst undertaking cognitive tasks with TCD monitoring.
Blood pressure monitoring: Continuous blood pressure recording
Heart rate monitoring: Continuous heart rate monitoring
End tidal CO2 monitoring: Continuous ETCO2 monitoring
Addenbrooke's cognitive examination: Performance of a memory test
|
Healthy Controls
n=14 Participants
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
Transcranial doppler ultrasonography: Measurement of cerebral blood flow whilst undertaking cognitive tasks with TCD monitoring.
Blood pressure monitoring: Continuous blood pressure recording
Heart rate monitoring: Continuous heart rate monitoring
End tidal CO2 monitoring: Continuous ETCO2 monitoring
Addenbrooke's cognitive examination: Performance of a memory test
|
|---|---|---|---|---|
|
Number of Participants With Rejected Measurements
|
2 Participants
|
3 Participants
|
0 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: 8 monthsOverall, 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
Outcome measures
| Measure |
Mild Cognitive Impairment
n=12 Participants
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
Transcranial doppler ultrasonography: Measurement of cerebral blood flow whilst undertaking cognitive tasks with TCD monitoring.
Blood pressure monitoring: Continuous blood pressure recording
Heart rate monitoring: Continuous heart rate monitoring
End tidal CO2 monitoring: Continuous ETCO2 monitoring
Addenbrooke's cognitive examination: Performance of a memory test
|
Alzheimer Disease
n=13 Participants
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
Transcranial doppler ultrasonography: Measurement of cerebral blood flow whilst undertaking cognitive tasks with TCD monitoring.
Blood pressure monitoring: Continuous blood pressure recording
Heart rate monitoring: Continuous heart rate monitoring
End tidal CO2 monitoring: Continuous ETCO2 monitoring
Addenbrooke's cognitive examination: Performance of a memory test
|
Vascular Dementia
n=3 Participants
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
Transcranial doppler ultrasonography: Measurement of cerebral blood flow whilst undertaking cognitive tasks with TCD monitoring.
Blood pressure monitoring: Continuous blood pressure recording
Heart rate monitoring: Continuous heart rate monitoring
End tidal CO2 monitoring: Continuous ETCO2 monitoring
Addenbrooke's cognitive examination: Performance of a memory test
|
Healthy Controls
n=14 Participants
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
Transcranial doppler ultrasonography: Measurement of cerebral blood flow whilst undertaking cognitive tasks with TCD monitoring.
Blood pressure monitoring: Continuous blood pressure recording
Heart rate monitoring: Continuous heart rate monitoring
End tidal CO2 monitoring: Continuous ETCO2 monitoring
Addenbrooke's cognitive examination: Performance of a memory test
|
|---|---|---|---|---|
|
Number of Participants in Which Percentage Change in CBFv Can be Derived
|
10 Participants
|
10 Participants
|
3 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: 8 monthsOverall, 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).
Outcome measures
| Measure |
Mild Cognitive Impairment
n=12 Participants
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
Transcranial doppler ultrasonography: Measurement of cerebral blood flow whilst undertaking cognitive tasks with TCD monitoring.
Blood pressure monitoring: Continuous blood pressure recording
Heart rate monitoring: Continuous heart rate monitoring
End tidal CO2 monitoring: Continuous ETCO2 monitoring
Addenbrooke's cognitive examination: Performance of a memory test
|
Alzheimer Disease
n=13 Participants
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
Transcranial doppler ultrasonography: Measurement of cerebral blood flow whilst undertaking cognitive tasks with TCD monitoring.
Blood pressure monitoring: Continuous blood pressure recording
Heart rate monitoring: Continuous heart rate monitoring
End tidal CO2 monitoring: Continuous ETCO2 monitoring
Addenbrooke's cognitive examination: Performance of a memory test
|
Vascular Dementia
n=3 Participants
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
Transcranial doppler ultrasonography: Measurement of cerebral blood flow whilst undertaking cognitive tasks with TCD monitoring.
Blood pressure monitoring: Continuous blood pressure recording
Heart rate monitoring: Continuous heart rate monitoring
End tidal CO2 monitoring: Continuous ETCO2 monitoring
Addenbrooke's cognitive examination: Performance of a memory test
|
Healthy Controls
n=14 Participants
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
Transcranial doppler ultrasonography: Measurement of cerebral blood flow whilst undertaking cognitive tasks with TCD monitoring.
Blood pressure monitoring: Continuous blood pressure recording
Heart rate monitoring: Continuous heart rate monitoring
End tidal CO2 monitoring: Continuous ETCO2 monitoring
Addenbrooke's cognitive examination: Performance of a memory test
|
|---|---|---|---|---|
|
Number of Participants in Which the Change in the Autoregulation Index (ARI) Can be Derived
|
10 Participants
|
10 Participants
|
3 Participants
|
10 Participants
|
Adverse Events
Mild Cognitive Impairment
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Alzheimer Disease
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Vascular Dementia
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Healthy Controls
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place