Cerebral Vascular Reserve in Small Vessel Disease and Alzheimers Disease

• Sponsor: Bispebjerg Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05443308
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Anticipated Duration (Months): 9.8
• Patients Per Site Per Month: 5.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Alzheimer Disease; Dementia, Vascular	Diagnostic Test: Cerebral [15O]H2O PET before and after diamox infusion

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

• Study Type: Observational
• Anticipated Enrollment: 50 participants
• Observational Model: Case-Control
• Time Perspective: Cross-Sectional
• Official Title: Cerebral Vascular Reserve in Small Vessel Disease and Alzheimers Disease
• Actual Study Start Date: Jun 21, 2022
• Anticipated Primary Completion Date: Apr 15, 2023
• Anticipated Study Completion Date: Apr 15, 2023

Arms and Interventions

Arm	Intervention/Treatment
Alzheimer Disease patients with presumed Alzheimer disease and no known vascular, psychiatric or other major diseases age > 60 years	Diagnostic Test: Cerebral [15O]H2O PET before and after diamox infusion; 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	Diagnostic Test: Cerebral [15O]H2O PET before and after diamox infusion; 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	Diagnostic Test: Cerebral [15O]H2O PET before and after diamox infusion; Cerebral [15O]H2O PET before and after diamox infusion

Outcome Measures

Primary Outcome Measures

1. Vascular reserve perfusion [20 min after diamox infusion]

   Brain perfusion after diamox infusion (mL / min / 100 g tissue)

2. Vascular reserve change [20 min after diamox infusion]

   Change in Brain perfusion after diamox infusion (mL / min / 100 g tissue and %) compared to before diamox infusion

Eligibility Criteria

Criteria

• Ages Eligible for Study: 60 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Clinical Physiology and Nuclear Medicine, Copenhagen University Hospital Bispebjerg	Copenhagen	Copenhagen NV	Denmark	2400

Sponsors and Collaborators

• Bispebjerg Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Lisbeth Marner, MD, Associate professor, Bispebjerg Hospital
• ClinicalTrials.gov Identifier: NCT05443308
• Other Study ID Numbers: H-21076058
• First Posted: Jul 5, 2022
• Last Update Posted: Jul 5, 2022
• Last Verified: Jun 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Lisbeth Marner, MD, Associate professor, Bispebjerg Hospital: Positron-Emission Tomography; Perfusion
• Additional relevant MeSH terms: Alzheimer Disease; Dementia, Vascular; Acetazolamide

Study Results

No Results Posted as of Jul 5, 2022