Alzheimer'
Conditions
Interventions
Transcranial direct current stimulation 15 sessions in three weeks Anode site: dorsolateral prefrontal cortex Cathode site: right forehead Intensity: 2mA 30-minute stimulation per session
Sham st
Sponsors
National Center of Neurology and Psychiatry, Japan
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Participants who meets criteria of probable Alzheimer's disease defined by NINCDS-ADRDA research criteria. 2) Participants who meets criteria of depression in Alzheimers defined by NIMH criteria. 3) Participants who have been on fixed dose (including participants without any prescription) of antidepressants for at least two weeks on the screening visit. 4) Participants who have been on fixed dose (including participants not prescribed) of antidementia drugs (donepezil, rivastigmine, galantamine, and memantine) for at least for weeks on the screening visit. 5) Ambulatory participants with or without any aiding device 6) Participants who have one caregiver, who must live with the patient at least ten hours a week and must report the patient's behavior. 7) A study partner who can report how the participant is doing is needed. 8 ) Eligible family member must sign and give consent on behalf of participants, whereas participants can give assent.
Exclusion criteria
Exclusion criteria: 1) In case their cognitive deficits are better explained by another disease (e.g., cerebral infarction, Parkinson disease, multiple sclerosis, normotensive hydrocephalus). 2) In case they have history of epilepsy 3) In case they need treatment by antipsychotics due to significant psychotic symptoms 4) In case they have urgent risk of suicide or severe depression and any doctor require their hospitalization to psychiatric units. 5) In case they have history of ineffectiveness with electroconvulsive therapy (ECT) or transcranial direct current stimulation (tDCS) 6) In case ECT or tDCS is clinically contraindicated 7) In case they are taking benzodiazepines or antiepileptic drugs on the screening visit 8) In case they scored less than ten on Mini Mental State Exam (MMSE) or scored 3 or more on Clinical Dementia Rating (CDR) 9) GDS scores lower than 6 at baseline 10) Unable to agree video recording on evaluation interview
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Attrition rate related to any adverse event | — |
Secondary
| Measure | Time frame |
|---|---|
| Attrition rate related to tDCS Change from the baseline by the Cornel Scale for Depression in Dementia (CSDD) scores after 15 sessions ( three weeks). Change from the baseline by the CSDD scores after 10 sessions (two weeks) Change from the baseline by the Geriatric Depression Scale (GDS) scores after 5/10/15 sessions (one/two/three weeks) Change from the baseline by the Neuropsychiatric Inventory (NPI) scores after 10/15 sessions (two/three weeks) Change from the baseline by the Japanese version of Zarit Burden Index (J-ZBI) scores after 10/15 sessions (two/three weeks) Clinical Global Impression of Improvement (CGI-I) scores after 5/10/15 sessions (one/two/three weeks) Attrition rate of any cause All adverse events (frequency and content) All severe adverse events (SAEs) (frequency and content) | — |
Countries
Japan
Contacts
Public ContactYuma Yokoi
National Center of Neurology and Psychiatry, Japan Department of psychiatry
Outcome results
None listed