Phase
Condition
Lewy Body Dementia
Mental Disability
Dementia
Treatment
Electroencephalogram
3 Tesla MRI
Apolipoprotein E genetic test
Clinical Study ID
Ages 50-85 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion criteria for all study subjects:
right-handed participants;
monolingual native Italian speakers;
age between 50-85 years old;
normal or corrected-to-normal visual acuity;
oral and written informed consent to study participation.
if assuming psychotropic drugs (i.e., benzodiazepines, antipsychotics, antidepressants), they should be at stable dosage for more than 4 weeks.
Inclusion criteria for MCI patients:
diagnosis of amnestic MCI;
mini Mental State Examination (MMSE) score ≥ 24;
if assuming anticholinesterase inhibitors (i.e., galantamine, rivastigmine, donepezil) or memantine, they should be at stable dosage for more than 4 weeks;
available CSF AD biomarkers.
Inclusion criteria for patients with mild dementia:
diagnosis of AD dementia, FTD or LBD.
MMSE score ≥ 15;
if assuming anticholinesterase inhibitors (i.e., galantamine, rivastigmine, donepezil) or memantine, they should be at stable dosage for more than 4 weeks.
Exclusion criteria for patients:
secondary forms of cognitive impairment on the basis of historical data, neurologic examination, and cerebral neuroimaging findings;
very rapid cognitive decline that occurs over weeks or months, typically indicative of prion disease, neoplasm or metabolic disorders;
history of other systemic (including systemic neoplasms in the last 3 years and abnormal hepatorenal functions), neurologic (including epilepsy), psychiatric diseases, head injury, cardiovascular events, and cerebrovascular alterations;
alcohol and/or psychotropic drugs abuse;
enrolment in clinical trials testing disease-modifying drugs for AD during study;
contraindications to MRI study:
Cardiac pacemakers or other types of cardiac catheters;
metal splinters or fragments;
metal prostheses not compatible with the magnetic field generated during MRI;
claustrophobia.
- Women who are pregnant or intending to become pregnant during the study; breastfeeding women.
Exclusion criteria for healthy controls
History of other systemic (including systemic neoplasms in the last 3 years and abnormal hepatorenal functions), neurologic (including epilepsy), psychiatric diseases, head injury, cardiovascular events, and cerebrovascular alterations;
alcohol and/or psychotropic drugs abuse;
contraindications to MRI study (see above);
women who are pregnant or intending to become pregnant during the study; breastfeeding women.
Study Design
Study Description
Connect with a study center
IRCCSS San Raffaele
Milano, 20132
ItalySite Not Available

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