Cerebral Vascular Reserve in Small Vessel Disease and Alzheimers Disease

Alzheimer Disease Clinical Trial

Official title:

Cerebral Vascular Reserve in Small Vessel Disease and Alzheimers Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05443308
• Other study ID #: H-21076058
• Status: Recruiting
• Start date: June 21, 2022
• Est. completion date: April 15, 2023

Study information

• Verified date: June 2022
• Source: Bispebjerg Hospital
• Contact: Lisbeth Marner, MD, PhD
• Phone: +4591171938
• Email: lisbeth.marner[@]regionh.dk
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: April 15, 2023
• Est. primary completion date: April 15, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Dementia, Vascular

Intervention

Diagnostic Test:
• Cerebral [15O]H2O PET before and after diamox infusion
Cerebral [15O]H2O PET before and after diamox infusion

Locations

Country	Name	City	State
Denmark	Department of Clinical Physiology and Nuclear Medicine, Copenhagen University Hospital Bispebjerg	Copenhagen	Copenhagen NV

Sponsors (1)

Lead Sponsor	Collaborator
Bispebjerg Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vascular reserve perfusion	Brain perfusion after diamox infusion (mL / min / 100 g tissue)	20 min after diamox infusion
Primary	Vascular reserve change	Change in Brain perfusion after diamox infusion (mL / min / 100 g tissue and %) compared to before diamox infusion	20 min after diamox infusion