Dementia with Lewy bodies
Conditions
Interventions
Normal adult dosage is 7.5 g/day divided into 2 to 3 oral doses, and taken before or between meals. Dosage may be adjusted according to the patient'
s age, weight and symptoms. Administration period: 8 weeks
Sponsors
Department of Geriatric Medicine, Kyorin University School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Probable DLB patients diagnosed according to the international consensus criteria for DLB. 2) Patients with 4 or more points at least one subscale of NPI at the start of treatment 3) Patients with serum potassium levels within the standard range of the facility when measured within 6 weeks before the start of treatment 4) Patients must have the same caregiver who can transport the patient to the hospital for consultation during the study. 5) Outpatients must have a reliable caregiver at home during the entire duration of the study who can transport the patient to the hospital for consultation 6) Inpatients must have been receiving care at their respective medical facility for least 2 weeks before the start of study
Exclusion criteria
Exclusion criteria: 1) Patients with malignancy, severe disease of heart, liver, renal, blood, lung and other life-threatening diseases 2) Patients who fail to meet the DSM-IV diagnostic criteria for our study, but show symptoms of BPSD due to other concomitant neurodegenerative disease, schizophrenia, bipolar disorder, major depression or other psychiatric disorders 3) Patients with delirium due to alcohol or drug addictions, metabolic poisoning, or inflammatory disease 4) Patients who are unable to take oral medications 5) Patients initiated the therapy with donepezil hydrochloride or made change in dosage and administration of the drug within 8 weeks before the start of treatment 6) Patients received drugs prohibited for concomitant use or drugs restricted in concomitant use during wash-out period, 7) Patients who took long acting antipsychotic drugs (such as haloperidol decanoate) within 4 weeks before the start of treatment 8) Patients who are determined as unfit for the study by attending physicians for reasons other than those stated above
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| NPI-D (administered at weeks 8 after the start of treatment) | — |
Secondary
| Measure | Time frame |
|---|---|
| MMSE, Barthel Index, cerebral blood flow (administered at week 8 after the start of treatment) | — |
Countries
Japan
Contacts
Public ContactKoichi Kozaki
Kyorin University Department of Geriatric Medicine, Kyorin University School of Medicine
Outcome results
None listed