Alzheimer DiseaseNCT05443308
Cerebral Vascular Reserve in Small Vessel Disease and Alzheimers Disease
An observational study of Alzheimer Disease and Dementia, Vascular, run by Bispebjerg Hospital at 1 site in Denmark.
Trial summary
Alzheimers disease and cerebral small vessel disease have a considerably overlap in patients and have common risk factors. The diseases are difficult to separate in individual patients and we hypothesize that a reduced cerebral vascular reserve may be a measurement of small vessel disease independent of Alzheimers… Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease, Dementia, Vascular
- What is being tested?
- Cerebral [15O]H2O PET before and after diamox infusion
- Type of treatment
- Injection or infusion
- How many people
- 50 participants
- Where
- 1 siteDenmark
- Study dates
- 21 Jun 2022to 15 Apr 2023
- 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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Recruited from Department of Neurology, and Department of Geriatric and Palliative Medicine at Bispebjerg Hospital, Copenhagen, Denmark. Healthy subjects are recruited from internet advertisments.
Who may be able to join
- presumed Alzheimer's Disease (group 1)
- diagnosed with small vessel disease of the brain by MRI and presumed cognitive dysfunction (group 2)
Who cannot join
- major claustrophobia
- major psychiatric diseases
- other major somatic diseases
- allergy to diamox
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Department of Clinical Physiology and Nuclear Medicine, Copenhagen University Hospital Bispebjerg
Copenhagen, Copenhagen NV, 2400
Lisbeth Marner, +4591171938, lisbeth.marner@regionh.dk
About this study
Alzheimers disease and cerebral small vessel disease have a considerably overlap in patients and have common risk factors. The diseases are difficult to separate in individual patients and we hypothesize that a reduced cerebral vascular reserve may be a measurement of small vessel disease independent of Alzheimers disease.
Patients with presumed Alzheimers disease (n=20), cerebral small vessel disease (n=20) and healthy age-matched subjects (n=15) are examined with quantitative [15O]H2O positron emission tomography (PET) for measurements of brain perfusion before and after diamox infusion that dilates cerebral vessels. Additional [15O]H2O PET scans of the heart allows for a non-invasive input function so the cerebral vascular reserve can be measured quantitatively.
Read the detailed description
Alzheimers disease and cerebral small vessel disease are increasingly common in the elderly population and constitute around 90% of new dementia cases in Denmark. The diseases have a considerably overlap in patients and have common risk factors. The cause of dementia can be difficult to separate in individual patients but a reduced cerebral vascular reserve may be a measurement of small vessel disease independent of Alzheimers disease. We hypothesized that patient with small vessel disease have reduced increase in brain perfusion after medical brain vessel dilatation. While Alzheimer patients may have reduced perfusion in rest but normal increase after medical brain vessel dilatation as compared to healthy subjects.
Patients with presumed Alzheimers disease (n=20), cerebral small vessel disease (n=20) and healthy age-matched subjects (n=15) are examined with quantitative [15O]H2O PET for measurements of brain perfusion before and after diamox infusion that dilates cerebral vessels. Additional [15O]H2O PET scans of the heart allows for a non-invasive input function so the cerebral vascular reserve can be measured quantitatively.
- Conditions
- Alzheimer Disease, Dementia, Vascular
- Being tested
- Cerebral [15O]H2O PET before and after diamox infusion
- Keywords
- Positron-Emission Tomography, Perfusion
- Medical subject headings
- Alzheimer Disease, Dementia, Vascular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cerebral [15O]H2O PET before and after diamox infusionDiagnostic test
Cerebral [15O]H2O PET before and after diamox infusion
| Study group | Role | What they receive |
|---|---|---|
| Alzheimer Disease | patients with presumed Alzheimer disease and no known vascular, psychiatric or other major diseases age > 60 years Receives: Diagnostic Test: Cerebral [15O]H2O PET before and after diamox infusion | |
| Small vessel disease | patients diagnosed with small vessel disease of the brain by MRI and presumed cognitive dysfunction and no other known psychiatric or other major diseases.
age > 60 years Receives: Diagnostic Test: Cerebral [15O]H2O PET before and after diamox infusion | |
| Healthy subjects | Age-matched subjects with no known vascular, psychiatric or other major diseases.
age > 60 years Receives: Diagnostic Test: Cerebral [15O]H2O PET before and after diamox infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vascular reserve perfusion
Brain perfusion after diamox infusion (mL / min / 100 g tissue)
Measured: 20 min after diamox infusion
Vascular reserve change
Change in Brain perfusion after diamox infusion (mL / min / 100 g tissue and %) compared to before diamox infusion
Measured: 20 min after diamox infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2022
- Study start21 Jun 2022
- Primary completion15 Apr 2023 (estimated)
- Study completion15 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies 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
- Cross-sectional
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bispebjerg Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lisbeth Marner, Bispebjerg Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05443308
- Sponsor's protocol ID
- H-21076058
- Status last verified
- Jun 2022
- First submitted
- 23 Jun 2022
- Last updated
- 5 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data will be available at reasonable request following Danish laws on personal data regulations.
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cerebral Vascular Reserve in Small Vessel Disease and Alzheimers Disease
- ClinicalTrials.gov ID
- NCT05443308
- Acronym / sponsor ID
- H-21076058
- Conditions
- Alzheimer Disease, Dementia, Vascular
- Keywords
- Positron-Emission Tomography, Perfusion
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Bispebjerg HospitalUniversity, hospital or other
- Study start
- 21 Jun 2022 (actual)
- Primary completion
- 15 Apr 2023 (estimated)
- Study completion
- 15 Apr 2023 (estimated)
- First posted
- 5 Jul 2022 (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.
Alzheimers disease and cerebral small vessel disease have a considerably overlap in patients and have common risk factors. The diseases are difficult to separate in individual patients and we hypothesize that a reduced cerebral vascular reserve may be a measurement of small vessel disease independent of Alzheimers disease.
Patients with presumed Alzheimers disease (n=20), cerebral small vessel disease (n=20) and healthy age-matched subjects (n=15) are examined with quantitative [15O]H2O positron emission tomography (PET) for measurements of brain perfusion before and after diamox infusion that dilates cerebral vessels. Additional [15O]H2O PET scans of the heart allows for a non-invasive input function so the cerebral vascular reserve can be measured quantitatively.
Detailed description
Alzheimers disease and cerebral small vessel disease are increasingly common in the elderly population and constitute around 90% of new dementia cases in Denmark. The diseases have a considerably overlap in patients and have common risk factors. The cause of dementia can be difficult to separate in individual patients but a reduced cerebral vascular reserve may be a measurement of small vessel disease independent of Alzheimers disease. We hypothesized that patient with small vessel disease have reduced increase in brain perfusion after medical brain vessel dilatation. While Alzheimer patients may have reduced perfusion in rest but normal increase after medical brain vessel dilatation as compared to healthy subjects.
Patients with presumed Alzheimers disease (n=20), cerebral small vessel disease (n=20) and healthy age-matched subjects (n=15) are examined with quantitative [15O]H2O PET for measurements of brain perfusion before and after diamox infusion that dilates cerebral vessels. Additional [15O]H2O PET scans of the heart allows for a non-invasive input function so the cerebral vascular reserve can be measured quantitatively.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Alzheimer Disease | – | Diagnostic Test: Cerebral [15O]H2O PET before and after diamox infusionpatients with presumed Alzheimer disease and no known vascular, psychiatric or other major diseases age > 60 years |
| Small vessel disease | – | Diagnostic Test: Cerebral [15O]H2O PET before and after diamox infusionpatients diagnosed with small vessel disease of the brain by MRI and presumed cognitive dysfunction and no other known psychiatric or other major diseases. age > 60 years |
| Healthy subjects | – | Diagnostic Test: Cerebral [15O]H2O PET before and after diamox infusionAge-matched subjects with no known vascular, psychiatric or other major diseases. age > 60 years |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Recruited from Department of Neurology, and Department of Geriatric and Palliative Medicine at Bispebjerg Hospital, Copenhagen, Denmark. Healthy subjects are recruited from internet advertisments.
Key inclusion criteria (2 listed)
- presumed Alzheimer's Disease (group 1)
- diagnosed with small vessel disease of the brain by MRI and presumed cognitive dysfunction (group 2)
Key exclusion criteria (4 listed)
- major claustrophobia
- major psychiatric diseases
- other major somatic diseases
- allergy to diamox
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 |
|---|---|---|
| Cerebral [15O]H2O PET before and after diamox infusionCerebral [15O]H2O PET before and after diamox infusion | Diagnostic test | Alzheimer Disease, Healthy subjects, Small vessel disease |
Primary outcome
Vascular reserve perfusion
Time frame: 20 min after diamox infusion
Brain perfusion after diamox infusion (mL / min / 100 g tissue)
Vascular reserve change
Time frame: 20 min after diamox infusion
Change in Brain perfusion after diamox infusion (mL / min / 100 g tissue and %) compared to before diamox infusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2022.
- Individual participant dataSharing planned: Undecided. Data will be available at reasonable request following Danish laws on personal data regulations.
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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.
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 Alzheimer Disease and Dementia, Vascular, run by Bispebjerg Hospital at 1 site in Denmark.
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 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: status not confirmed, as of the sponsor's last update on 5 Jul 2022. 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 Denmark. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lisbeth Marner, MD, PhD (+4591171938, lisbeth.marner@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vascular reserve perfusion (time frame: 20 min after diamox infusion). The study lists 2 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 5 Jul 2022.