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Clarifying the vascular aspects of dementia

Clarifying the vascular aspects of dementia

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON26538
Enrollment
280
Registered
2019-09-25
Start date
2019-08-20
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

dementia

Interventions

none

Sponsors

none
Lead Sponsor

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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 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

Contacts

Public ContactSanneke van Rooden

LUMC

S.van_Rooden@lumc.nl0715265482

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)