Coach Pilot Study: Assessing Cognitive Function and Related Small Vessel Disease Markers After Intracerebral Hemorrhage

NCT05499169 | Terminated

• 1 other identifier: P20.109
• Study Type: observational
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

The overall aim of this pilot study is to investigate the development of magnetic resonance imaging (MRI) and cerebrospinal fluid (CSF) markers after cerebral amyloid angiopathy (CAA)-related and hypertensive arteriopathy (HA)-related intracerebral hemorrhage (ICH) in relation to cognitive decline. The results from this pilot trial will be used to design a larger cohort study to investigate underlying mechanisms of cognitive decline after ICH. The study population consists of 32 patients; 16 patients with CAA-related ICH and 16 patients with HA-related ICH who are 55 years or older. Data will be collected at four measuring points: at baseline (during hospital admission for the ICH or at the outpatients clinic within one month of presentation with an acute ICH), after three months, after six months and after 12 months. Premorbid cognitive functioning will be assessed with the Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE) to select participants without pre-existing cognitive impairment.

Conditions

Cerebral Amyloid Angiopathy; Intracerebral Hemorrhage; Hypertensive Hemorrhage, Intracranial; Cognitive Decline

Outcome Measures

Primary Outcomes (1)

• Cognitive decline (according to the neuropsychological assessment)

  New onset cognitive impairment and dementia will be determined according to the Mini-Mental State Examination (MMSE) and compared between CAA-related and HA-related ICH.

  12 months after ICH

Secondary Outcomes (5)

• Burden of SVD markers on MRI markers at baseline, at six months and at 12 months

  Baseline, at six months and at 12 months

• Concentrations of p-tau181 in CSF at baseline, at six months and at 12 months

  Baseline, at six months and at 12 months

• Concentrations of Aβ40 in CSF at baseline, at six months and at 12 months

  At baseline, at six months and at 12 months

• Concentrations of Aβ42 in CSF at baseline, at six months and at 12 months

  At baseline, at six months and at 12 months

• Concentrations of t-tau in CSF at baseline, at six months and at 12 months

  At baseline, at six months and at 12 months

Study Arms (2)

16 patients with CAA-related ICH

16 patient above the age of 55 that fit the inclusion criteria. CAA-related ICH is defined as an ICH that meets the criteria for definite or probable CAA according to the Modified Boston Criteria.

16 patients with HA-related ICH

16 patient above the age of 55 that fit the inclusion criteria. HA-related ICH is defined as ICH located in the basal ganglia, thalamus, or the deep white matter and the presence of hypertension defined as: on treatment for hypertension, or known with high blood pressure (two measurements systolic blood pressure (SBP) \>140 or diastolic blood pressure (DBP) \>90 mmHg) but not treated for hypertension.

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study population are patients with ICH that have no family history of hereditary forms of ICH such as hereditary CAA (HCHWA-D) and no cognitive impairment before the ICH. Patients will be aged ≥ 55y, since the radiological Boston criteria for CAA-related ICH only include patients ≥ 55y.

You may qualify if:

• Age ≥ 55y
• Ability and willingness to provide written informed consent.
• Supratentorial ICH with CAA or HA as the most likely cause.

You may not qualify if:

• Age \< 55y
• Unable to provide informed consent.
• Pre-existing cognitive impairment assessed with the Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE); scores between 53 - 63 reflect pre-existing cognitive impairment
• Contra indications, such as: Contra-indications for 3T MRI. Examples of possible contra-indications are:
• Claustrophobia
• Pacemakers and defibrillators
• Nerve stimulators
• Intracranial clips
• Intra-orbital or intraocular metallic fragments
• Cochlear implants
• Ferromagnetic implants
• Hydrocephalus pump
• Intra-uterine device
• Permanent make-up
• Tattoos above the shoulders

Sponsors & Collaborators

• Leiden University Medical Center: lead

Study Sites (1)

Leiden University Medical Center

Leiden, South Holland, 2333 ZA, Netherlands

Location

Biospecimen

Retention: SAMPLES WITH DNA

If participants give permission for Leiden University Medical Center (LUMC) Biobank sporadic cerebral amyloid angiopathy (sCAA) (part of the LUMC Biobank Neurological Diseases), an additional 50 ml blood will be drawn. These blood samples will be stored for future (yet unknown) biomarker analysis after approval of the participants. These blood samples will be handled confidentially and coded and will be stored in the LUMC Biobank sCAA Neurological Diseases. The regulations of the LUMC Biobank Neurological Diseases will be applicable to the LUMC Biobank sCAA under Neurological Diseases

MeSH Terms

Conditions

Cerebral Amyloid Angiopathy; Cerebral Hemorrhage; Intracranial Hemorrhage, Hypertensive; Cognitive Dysfunction

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; Intracranial Hemorrhages; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Ellis van Etten, MD, PhD

  Leiden University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: August 1, 2022
• First Posted: August 12, 2022
• Study Start: April 3, 2022
• Primary Completion: April 3, 2023
• Study Completion: April 3, 2023
• Last Updated: November 18, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)