High Frequency Imaging in Cerebral Amyloid Angiopathy

NCT06128824 | Active Not Recruiting

• 1 other identifier: HIFI-CAA-01
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 3

Brief Summary

Cerebral amyloid angiopathy (CAA), caused by amyloid beta depositions in the walls of small cerebral vessels, is remarkably common in the elderly. Its major clinical consequences include intracerebral hemorrhages (ICH) typically in lobar location, functional dependence (disability) and cognitive impairment. Cortical superficial siderosis (cSS) is a common finding in CAA patients and can even be the only magnetic resonance imaging sign of CAA. cSS is of high prognostic relevance regarding future intracerebral haemorrhage and disability. Previous studies suggest that cSS is caused by recurrent focal subarachnoid hemorrhages (fSAH). However, the exact mechanisms and the temporal dynamics of this highly relevant imaging finding are largely unknown. In addition to hemorrhagic manifestations, such as cSS, CAA patients also show ischemic lesions. Of particular interest are acute ischemic lesions as detected by diffusion imaging, which seem to be highly prevalent. Since haemorrhagic and ischemic lesions require fundamentally different therapeutic strategies, understanding the relevance and interplay of both lesion types is highly important for clinical decision making. The HIFI-CAA cohort study aims to provide novel insights into cSS, acute ischemic lesions and other relevant brain alterations in CAA through high-frequency (monthly) serial magnetic resonance imaging.

Conditions

Cerebral Amyloid Angiopathy

Keywords

cortical superficial siderosis; DWI+ lesion; serial imaging; disease progression; MRI; cerebrovascular events; focal subarachnoid hemorrhage

Outcome Measures

Primary Outcomes (1)

• new hemorrhagic features as determined by heme-sensitive MRI

  new hemorrhagic features (e.g., cSS) as determined by heme-sensitive magnetic resonance imaging such as T2\*-weighted gradient echo (GRE) and susceptibility weighted imaging (SWI)

  monthly up to 12 months

Secondary Outcomes (6)

• DWI+ lesions on diffusion weighted imaging MRI

  monthly up to 12 months

• modified Rankin Scale

  monthly up to 12 months

• neuropsychological evaluation (global cognition using MoCA)

  baseline and after 12 months

• neuropsychological evaluation (global cognition using MMSE)

  baseline and after 12 months

• neuropsychological evaluation (processing speed and executive function)

  baseline and after 12 months

Study Arms (2)

Patients with probable CAA and cSS or fSAH

Patients with probable CAA and cortical superficial siderosis (cSS) or focal subarachnoid haemorrhage (fSAH)

Other: MR Imaging

Patients with probable CAA without cSS or fSAH

Patients with probable CAA and intracerebral hemorrhage (ICH; micro- or macrohemorrhage) but without cSS or fSAH

Other: MR Imaging

Interventions

MR Imaging OTHER

Serial magnetic resonance imaging (MRI)

Patients with probable CAA and cSS or fSAH; Patients with probable CAA without cSS or fSAH

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study will be performed in a hospital-based setting. Patients with probable CAA according to the modified Boston criteria or Boston criteria v2.0 will be further evaluated for study participation.

You may qualify if:

• Probable CAA according to the modified Boston criteria with evidence of
• cSS or fSAH
• lobar ICH survivors without cSS or fSAH
• Absence of ICH or microbleed in deep locations (basal ganglia, thalamus, brain stem)
• Absence of infratentorial siderosis or infratentorial SAH
• MR-/CT-/DS-angiography without evidence of cerebral aneurysm, AVM, AV-fistula or other possible etiology for the observed haemorrhagic manifestations
• No history of head trauma resulting in loss of consciousness or radiologically visible traumatic brain injury
• Written informed consent by patient herself/himself prior to study enrolment

You may not qualify if:

• Unwillingness to participate in high-frequency (monthly) follow-up
• Severe medical condition with expected life expectancy \<1 year
• Contraindications for MRI (following local guidelines of the respective study center)

Sponsors & Collaborators

• Martin Dichgans: lead

Study Sites (3)

DZNE/Bonn - Klinik und Poliklinik für Neurologie, Universitätsklinikum Bonn

Bonn, Germany

Location

DZNE/Magdeburg - Universitätsklinikum Magdeburg

Magdeburg, Germany

Location

Insitute for Stroke and Dementia Research

Munich, 81377, Germany

Location

MeSH Terms

Conditions

Cerebral Amyloid Angiopathy; Disease Progression

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Cerebral Arterial Diseases; Intracranial Arterial Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Amyloidosis; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Marco Duering, MD

  Institute for Stroke and Dementia Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: October 26, 2023
• First Posted: November 13, 2023
• Study Start: March 19, 2019
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): May 31, 2026
• Last Updated: September 12, 2025

Record last verified: 2025-09

Locations

DE (3)