Mild Cognitive ImpairmentRICBDENCT04168021
Remote Ischemic Conditioning of the Human Brain in Dementia Patients
A study testing Leg ischemia in people with Mild Cognitive Impairment and Dementia, run by Aristotle University Of Thessaloniki.
Trial summary
The study investigates the incidence of remote ischemic conditioning in mild cognitive impairment and dementia patients Read more about this study
- Who is it for?
- Ages 65 to 95 years
- Conditions the study is for
- Mild Cognitive Impairment, Dementia, Intermittent Claudication
- What is being tested?
- Leg ischemia
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2020to 31 Dec 2021
- Phase
- Interventional
- 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 65 to 95 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Clinical diagnosis of mild cognitive impairment
- Clinical diagnosis of mild dementia
- Clinical diagnosis of moderate dementia
- Peripheral arteriopathy
Who cannot join
- Clinical diagnosis of severe dementia
- Not being able to follow the exercise program for more than two days for any reason
About this study
Official title: Remote Ischemic Conditioning of the Human Brain in Dementia Patients (RICBDE): Protocol for a Crossover Non-pharmaceutical Intervention Study
The study investigates the incidence of remote ischemic conditioning in mild cognitive impairment and dementia patients
Read the detailed description
The investigators will study the potential neuroprotection of ischemia/reperfusion (I/R) of a peripheral organ or tissue against cerebral I/R injury in people with mild cognitive impairment as well as early and middle stage dementia.
This crossover study will be held with individuals suffering from peripheral arteriopathy that can cause intermittent claudication after structured exercise, thus inducing extensive transient leg's ischemia.
- Being tested
- Leg ischemia
- Medical subject headings
- Cognitive Dysfunction, Dementia, Intermittent Claudication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Leg ischemiaBehavioural
potential neuroprotection of ischemia/reperfusion of a peripheral organ or tissue against cerebral I/R injury
| Study group | Role | What they receive |
|---|---|---|
| Group 90 individuals, baseline assessment before intervention | No intervention | Baseline Cognitive status assessment |
| Remote ischemic condition of the brain | Experimental | Intermittent claudication induction on a daily basis for 1 month Receives: Behavioral: Leg ischemia |
| Late cognitive assessment | No intervention | Late cognitive status assessment 6 months later |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurements to Assess General Cognitive Function
Change in Mini Mental State Examination (minimum value 10 - maximum value 30, higher scores mean a better outcome)
Measured: Baseline, 1 and 6 months
Neuropsychological Assessment
Change Test (higher scores mean a better outcome)
Measured: Baseline, 1 and 6 months
Changes in Functional Cognitive State
Global Deterioration Scale (values 1-7, higher scores mean a worse outcome)
Measured: Baseline, 1 and 6 months
Secondary outcomes (3)
NeuroImaging
Magnetic Resonance Imaging (MRI) (white matter hyperintensities volume)
Measured: baseline, 1 month, 6 months
Neurophysiology
Changes in Event-Related Potential (ERP) (oddball paradigm, auditory ERPs)
Measured: Baseline, 1 month, 12 months
Electroencephalography recording
Changes in Electroencephalography (EEG), resting state
Measured: Baseline, 1 month, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2019
- Study start1 Jan 2020 (estimated)
- Primary completion31 Aug 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- More trials run by Aristotle University Of ThessalonikiThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aristotle University Of Thessaloniki
- Sponsor type
- University, hospital or other
- Collaborators
- Greek Alzheimer's Association and Related Disorders
- Responsible party
- Principal investigator, Magda Tsolaki, Aristotle University Of Thessaloniki
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04168021
- Sponsor's protocol ID
- BrainIRC
- Acronym
- RICBDE
- Status last verified
- Nov 2019
- First submitted
- 10 Nov 2019
- Last updated
- 19 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data will be available. Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices) will be shared. Study Protocol and Informed Consent Form will also be available. Data will be available (start and end dates) immediately following publication, No end date, with Investigations whose proposed use of the data has been approved by an independent review committee identified for this purpose, and for any purpose types of analysis.
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remote Ischemic Conditioning of the Human Brain in Dementia Patients (RICBDE): Protocol for a Crossover Non-pharmaceutical Intervention Study
- ClinicalTrials.gov ID
- NCT04168021
- Acronym / sponsor ID
- RICBDE / BrainIRC
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Aristotle University Of ThessalonikiUniversity, hospital or other
- Collaborators
- Greek Alzheimer's Association and Related Disorders
- Study start
- 1 Jan 2020 (estimated)
- Primary completion
- 31 Aug 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 19 Nov 2019 (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.
The study investigates the incidence of remote ischemic conditioning in mild cognitive impairment and dementia patients
Detailed description
The investigators will study the potential neuroprotection of ischemia/reperfusion (I/R) of a peripheral organ or tissue against cerebral I/R injury in people with mild cognitive impairment as well as early and middle stage dementia.
This crossover study will be held with individuals suffering from peripheral arteriopathy that can cause intermittent claudication after structured exercise, thus inducing extensive transient leg's ischemia.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 90 individuals, baseline assessment before intervention | No intervention | –Baseline Cognitive status assessment |
| Remote ischemic condition of the brain | Experimental | Behavioral: Leg ischemiaIntermittent claudication induction on a daily basis for 1 month |
| Late cognitive assessment | No intervention | –Late cognitive status assessment 6 months later |
Who may qualify
- Ages
- 65 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Clinical diagnosis of mild cognitive impairment
- Clinical diagnosis of mild dementia
- Clinical diagnosis of moderate dementia
- Peripheral arteriopathy
Key exclusion criteria (2 listed)
- Clinical diagnosis of severe dementia
- Not being able to follow the exercise program for more than two days for any reason
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 |
|---|---|---|
| Leg ischemiapotential neuroprotection of ischemia/reperfusion of a peripheral organ or tissue against cerebral I/R injury | Behavioural | Remote ischemic condition of the brain |
Primary outcome
Measurements to Assess General Cognitive Function
Time frame: Baseline, 1 and 6 months
Change in Mini Mental State Examination (minimum value 10 - maximum value 30, higher scores mean a better outcome)
Neuropsychological Assessment
Time frame: Baseline, 1 and 6 months
Change Test (higher scores mean a better outcome)
Changes in Functional Cognitive State
Time frame: Baseline, 1 and 6 months
Global Deterioration Scale (values 1-7, higher scores mean a worse outcome)
3 secondary outcomes
NeuroImaging
Time frame: baseline, 1 month, 6 months
Neurophysiology
Time frame: Baseline, 1 month, 12 months
Electroencephalography recording
Time frame: Baseline, 1 month, 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2019.
- Individual participant dataSharing planned: Yes. Individual participant data will be available. Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices) will be shared. Study Protocol and Informed Consent Form will also be available. Data will be available (start and end dates) immediately following publication, No end date, with Investigations whose proposed use of the data has been approved by an independent review committee identified for this purpose, and for any purpose types of analysis.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Leg ischemia in people with Mild Cognitive Impairment and Dementia, run by Aristotle University Of Thessaloniki.
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 4 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 19 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Measurements to Assess General Cognitive Function (time frame: Baseline, 1 and 6 months). The study lists 3 primary outcomes in all. 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 19 Nov 2019.