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Clinical Trials/NCT05443308
NCT05443308
Unknown
Not Applicable

Cerebral Vascular Reserve in Small Vessel Disease and Alzheimers Disease

Bispebjerg Hospital1 site in 1 country50 target enrollmentJune 21, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Alzheimer Disease
Sponsor
Bispebjerg Hospital
Enrollment
50
Locations
1
Primary Endpoint
Vascular reserve perfusion
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 21, 2022
End Date
April 15, 2023
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Lisbeth Marner

MD, Associate professor

Bispebjerg Hospital

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

Outcomes

Primary Outcomes

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

Study Sites (1)

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