Dementie Alzheimer dementia Alzheimers disease Cerebral amyloid angiopathy
Conditions
Interventions
None listed
Sponsors
Radboud Universitair Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Patients with CAA: To be eligible to participate, a subject must meet the following criteria: 1) Fulfilment of the Boston criteria 2.0 for CAA; 2) Subjects are mentally competent to take a decision on participation; 3) Most recent ICH was at least 6 months ago; 4) Age >50 years; 5) Written informed consent; 6) If participant participated in the BIONIC/CAFÉ study: Lumbar puncture at baseline visit successfully acquired CSF. Patients with AD: To be eligible to participate, a subject must meet the following criteria: 1) Fulfilment of the NIA-AA criteria for probable AD. 2) Subjects are mentally competent to take a decision on participation; 3) Written informed consent; 4) Age >50 years; 5) If participant participated in the BIONIC/CAFÉ study: Lumbar puncture at baseline visit successfully acquired CSF. Control cases: To be eligible to participate, a subject must meet the following criteria: 1) Age >50 years; 2) A MoCA score >=27 3) Subjects are mentally competent to take a decision on participation; 4) Written informed consent
Exclusion criteria
Exclusion criteria: Exclusion CAA: 1) Presence of blood coagulopathy, established by medical history; 2) History of major psychiatric disorder; 3) Pregnancy at time of study participation; 4) Allergy to local anesthetic agents; 5) Contra-indication for lumbar puncture: medical history of compression of spinal cord, spinal surgery, skin infection, developmental abnormalities in lower spine; 6) Subjects who are currently participating in another study or have participated in a clinical study within the previous 30 days, based on their own report; 7) Subjects with a history or current drug or alcohol abuse; 8) Subjects who are part of the study staff personnel or family members of the study staff personnel. 9) Proven mutation carrier for the D-CAA (tested only on clinical indication) 10) Contra-indications for MRI Exlcusion AD: 1) Presence of blood coagulopathy, confirmed by medical history; 2) History of major psychiatric disorder; 3) Pregnancy at time of study participation 4) Allergy to local anesthetic agents; 5) Contra-indication for lumbar puncture: medical history of compression of spinal cord, spinal surgery, skin infection, developmental abnormalities in lower spine; 6) Subjects who are currently participating in another study or have participated in a clinical study within the previous 30 days, based on their own report ; 7) Subjects with a history or current drug or alcohol abuse; 8) Proven mutation carrier for a gene known to be associated with early-onset hereditary AD (tested only on clinical indication) 9) Subjects who are part of the study staff personnel or family members of the study staff personnel. Exclusion control cases: 1) Self-reported (subjective) cognitive decline; 2) History of major neurological (e.g. stroke, neurodegenerative disease, brain tumours, brain infection or inflammation) or psychiatric disorder; 3) Pregnancy at time of study participation 4) Presence of blood coagulopathy, confirmed by medical history; 5) Allergy to local anesthetic agents; 6) Contra-indication for lumbar puncture: medical history of compression of spinal cord, spinal surgery, skin infection, developmental abnormalities in lower spine; 7) Subjects who are currently participating in another study or have participated in a clinical study within the previous 30 days, based on their own report ; 8) Subjects with a history or current drug or alcohol abuse; 9) Proven mutation carrier for a gene known to be associated with early-onset hereditary AD (tested only on clinical indication) or D-CAA 10) Subjects who are part of the study staff personnel or family members of the study staff personnel. 11) Contra-indications for MRI
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary objective: Describe the longitudinal changes of Aβ38, Aβ40, Aβ42, and Aβ43 concentrations in CSF of patients with CAA, AD, and healthy control cases and estimate the differences in change between those groups. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Quantified volume of cerebral perivascular gadolinium signal and structural features in CAA patients 2. Biomarker assays for BBB-dysfunction detection 3. Correlations between biomarker concentrations with Aβ in the study populations 4. Correlation between biomarker concentrations and gadolinium signal 5. Correlation analysis between APOE and BBB-dysfunction biomarker and the Aβ peptides | — |
Countries
Netherlands
Outcome results
None listed