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Clarifying the vascular aspects of dementia

Recruiting
Conditions
dementia
Registration Number
NL-OMON26538
Lead Sponsor
none
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
Not specified
Target Recruitment
280
Inclusion Criteria

In order to be eligible to participate in this study, a subject must meet the following criteria:

Patients who attended the memory clinic of the Leiden University Medical Center/ Bronovo hospital within one year ago
•Diagnosed with probable AD
•Diagnosed as MCI
•Diagnosed as SCI
•Diagnosed as VaD
•Capable of giving informed consent (see appendix)

Control subjects
•Healthy adults without memory complaints aged between 40-90 years old

Exclusion Criteria

A potential subject who meets any of the following criteria will be excluded from participation in this study:

- 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 study30)
- Severe physical restrictions (completely wheelchair dependent)
- Age above 90

Study & Design

Study Type
Observational non invasive
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
The change in BOLD signal in response to visual stimulation including the amplitude of the BOLD response in percentage signal change between stimulus on and off, time-to-peak response (sec), and time-to-baseline (sec) after discontinuation of the visual stimulus will be analyzed.4, 5 Only normal appearing tissue will be taken for analysis.
Secondary Outcome Measures
NameTimeMethod
Classic signs of CAA will be determined according to the Boston criteria26: intracranial hemorrhage, lobar microbleeds, subarachnoidal hemorrhage and superficial siderosis will be scored as previously described.31 <br>Also other cerebral SVD markers will be scored: number of small subcortical infarcts and lacunes32, volume of WMHs33, perivascular spaces in the basal ganglia and centrum semiovale34, number and location of microbleeds35 and grey matter volume using Sienax.36 <br>
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