Mechanisms Of DEMentia - Longitudinal Amyloid-beta Measurements and Blood-brain barrier Dysfunction in Alzheimer and CAA

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 90

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 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

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary objective:<br /><br>Describe the longitudinal changes of Aβ38, Aβ40, Aβ42, and Aβ43 concentrations<br /><br>in CSF of patients with CAA, AD, and healthy control cases and estimate the<br /><br>differences in change between those groups.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>1. Quantified volume of cerebral perivascular gadolinium signal and structural<br /><br>features in CAA patients<br /><br>2. Biomarker assays for BBB-dysfunction detection<br /><br>3. Correlations between biomarker concentrations with Aβ in the study<br /><br>populations<br /><br>4. Correlation between biomarker concentrations and gadolinium signal<br /><br>5. Correlation analysis between APOE and BBB-dysfunction biomarker and the Aβ<br /><br>peptides</p><br>