Clinical trial NCT05443308: Cerebral Vascular Reserve in Small Vessel Disease and Alzheimers Disease
Official title: Cerebral Vascular Reserve in Small Vessel Disease and Alzheimers Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Alzheimer Disease
Dementia, Vascular
Keywords: Positron-Emission Tomography
Perfusion
Lead sponsor: Bispebjerg Hospital
Sponsor class: OTHER
First posted: 2022-07-05
Enrollment: 50
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

* presumed Alzheimer's Disease (group 1)
* diagnosed with small vessel disease of the brain by MRI and presumed cognitive dysfunction (group 2)

Exclusion Criteria:

* major claustrophobia
* major psychiatric diseases
* other major somatic diseases
* allergy to diamox

Primary outcomes:
measure: Vascular reserve perfusion
timeFrame: 20 min after diamox infusion
measure: Vascular reserve change
timeFrame: 20 min after diamox infusion
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Department of Clinical Physiology and Nuclear Medicine, Copenhagen University Hospital Bispebjerg
state: Copenhagen NV
Study officials:
References: