dementia with Lewy bodies (DLB) , Alzheimer'
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1)50-90 years of age, inclusive. 2)Patients with DLB, if applicable, who are identified as suffering from probable DLB according to the revised consensus criteria.Patients with AD, if applicable, who are identified as suffering from probable AD according to the NIAAA criteria, except for patients with probable AD who meet the criteria for possible DLB. To confirm this, the subject must have undergone sufficient clinical evaluation. 3)Mini Mental State Examination score between 14 to 26. 4)Results available from MRI or CT scan performed within 12 months prior to the screening visit to rule out possible vascular dementia. 5)Subject or responsible caregiver provides informed consent for the subject to participate in the research.
Exclusion criteria
Exclusion criteria: 1)Subject or responsible caregiver is unable or unwilling to give informed consent. 2)Presence of local or diffuse vascular lesions on MRI or CT, where this is thought to be the cause of, or contribute to the severity of the subject's dementia. 3)Suffering from a significant neurologic disease other than probable DLB or AD. 4)Systemic diseases possibly contributing to the severity of dementia. 5)History of alcohol or drug abuse or dependence within the past 2 years. 6)History of schizophrenia. 7)Any significant systemic illness or unstable medical condition that may affect EEG. 8)Use of specific medications: a)Centrally active beta-blockers (propranolol), methyldopa and clonidine within 4 weeks prior to screening, narcotics. b)Use of anti-Parkinsonism medications other than levodopacarbidopa, or levodopa benserazide within 4 weeks prior to screening. c)Neuroleptics or narcotic analgesics within 4 weeks prior to screening d)Long acting benzodiazepines or barbiturates within 4 weeks prior to screening e)Use of short-acting anxiolytics or sedative hypnotics more than 2 times per week within 4 weeks prior to screening. 9)Patients currently using memantine. Cholinesterase inhibitors are permitted if doses are stable for 4 weeks prior to screening. 10)Use of any investigational drugs within 30 days or 5 half lives prior to screening. 11)Subjects who, in the Principal Investigator's opinion, are unlikely to comply with the EEG recording procedure.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Accuracy of the EEG analysis program in identifying subjects with a diagnosis of probable DLB and subjects with a diagnosis of probable AD (on the basis of the clinical diagnostic criteria) | — |
Countries
Japan
Contacts
Osaka University United Graduate School of Child Development Department of Behavioral Neurology and Neuropsychiatry