Cerebral Vascular Reserve in Small Vessel Disease and Alzheimers Disease

NCT ID: NCT05443308

Last Updated: 2022-07-05

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-06-21
• Study Completion Date: 2023-04-15

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.

Conditions

Alzheimer Disease; Dementia, Vascular

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Alzheimer Disease

patients with presumed Alzheimer disease and no known vascular, psychiatric or other major diseases age \> 60 years

Cerebral [15O]H2O PET before and after diamox infusion

Intervention Type: 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

Cerebral [15O]H2O PET before and after diamox infusion

Intervention Type: 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

Cerebral [15O]H2O PET before and after diamox infusion

Intervention Type: DIAGNOSTIC_TEST

Cerebral \[15O\]H2O PET before and after diamox infusion

Interventions

Cerebral [15O]H2O PET before and after diamox infusion

Cerebral \[15O\]H2O PET before and after diamox infusion

Intervention Type: DIAGNOSTIC_TEST

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

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Bispebjerg Hospital

OTHER

Sponsor Role: lead

Responsible Party

Lisbeth Marner

MD, Associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Department of Clinical Physiology and Nuclear Medicine, Copenhagen University Hospital Bispebjerg

Copenhagen, Copenhagen NV, Denmark

Site Status: RECRUITING

Countries

Denmark

Central Contacts

Lisbeth Marner, MD, PhD

Role: CONTACT

lisbeth.marner@regionh.dk

+4591171938

Facility Contacts

Lisbeth Marner

Role: primary

lisbeth.marner@regionh.dk

+4591171938

Other Identifiers

H-21076058

Identifier Type: -

Identifier Source: org_study_id