Clarifying the Vascular Aspects of Dementia; natural history study

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 120

Inclusion Criteria

In order to be eligible to participate in this study, a subject must meet the
inclusion all of the following criteria. For this study three different routes
for inclusion exists. Inclusion criteria for each group separately are shown
below.:

1. Participants who were included in our previous CASCADE study (P19.039).
* Capable of giving informed consent (see appendix)

2. Patients who attended the memory clinic of the Leiden University Medical
Center/ Haaglanden MC within one year ago
• Diagnosed with (mixed) probable AD
• Diagnosed as MCI
• Diagnosed as SCI
• Age between 50-90 years
• Capable of giving informed consent (see appendix)

3. Control subjects
• Healthy adults without memory complaints
• Age aged between 50-90 years old
• Capable of giving informed consent

Exclusion Criteria

A potential subject who meets any of the following criteria will be excluded
from participation in this study. For this study three different routes for
inclusion exists. Exclusion criteria for each group separately are shown below.

1. Participants who were included in our previous CASCADE study (P19.039).
• No MRI at previous CASCADE study (P19.039)

2. Patients who attended the memory clinic of the Leiden University Medical
Center/Haaglanden MC within one year ago
- Contra-indication to MRI scanning:
• Claustrophobia
• Pacemakers and defibrillators
• Nerve stimulators
• Intracranial clips
• Intraorbital or intraocular metallic fragments
• Cochlear implants
• Ferromagnetic implants
• Hydrocephaluspump
• Intra-utrine device (not all types)
• Permanent make-up
• Tattoos above the shoulders (not all)

- Specific contraindications to fMRI
• Seizure within prior year.
• Noncorrectable visual impairment.

- MMSE < 19 points (measured at moment of screening or at memory clinic with a
maximum of 6 months in retrospect) (this cutoff was also used in the Leiden
85-Plus study14)
- Severe physical restrictions (completely wheelchair dependent)
- Age above 90

3. Control subjects
- Contra-indication to MRI scanning:
• Claustrophobia
• Pacemakers and defibrillators
• Nerve stimulators
• Intracranial clips
• Intraorbital or intraocular metallic fragments
• Cochlear implants
• Ferromagnetic implants
• Hydrocephaluspump
• Intra-utrine device (not all types)
• Permanent make-up
• Tattoos above the shoulders (not all)

- Specific contraindications to fMRI
• Seizure within prior year.
• Noncorrectable visual impairment.

- MMSE < 19 points (measured at moment of screening or at memory clinic with a
maximum of 6 months in retrospect) (this cutoff was also used in the Leiden
85-Plus study14)
- Severe physical restrictions (completely wheelchair dependent)
- Age above 90

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>1) 3T MRI: the amplitude of the BOLD response in percentage signal change<br /><br>between stimulus on and off, time-to-peak response (sec), and time-to-baseline<br /><br>(sec) after discontinuation of the visual stimulus, classic signs of CAA<br /><br>(intracranial hemorrhage, lobar microbleeds, subarachnoidal hemorrhage and<br /><br>superficial siderosis) and SVD markers (number of small subcortical infarcts<br /><br>and lacunes, volume of white matter hyperintensities (WMHs), perivascular<br /><br>spaces in the basal ganglia and centrum semiovale, number and location of deep<br /><br>microbleeds and grey matter volume). 2) Neuropsychological assessment 3)<br /><br>Baseline characteristics, 4) DNA: APOE * genotype. </p><br>

Secondary Outcome Measures