Alzheimer Disease, Depression
Conditions
Keywords
Alzheimer's disease, Depressive symptoms, Neuropsychiatric symptoms, Behavioral and Psychological Symptoms of Dementia, Neuromodulation, Transcranial Direct Current Stimulation
Brief summary
This project will investigate the safety and efficacy of transcranial direct current stimulation (tDCS) in the treatment of depression among patients with Alzheimer's disease. The investigators aim to ameliorate depressive symptoms among patient with Alzheimer's disease, by anodal stimulation on left dorsolateral prefrontal cortex and cathodal suppression on right supraorbital area. Active stimulation will be compare to sham condition in 20 patients (10 in each groups).
Detailed description
This project will investigate the safety and efficacy of transcranial direct current stimulation (tDCS) in the treatment of depression among patients with Alzheimer's disease. tDCS causes an excitatory effect on the anode side and suppressing effect on the cathode side through sculp with very week currents (2 mA in this project). The investigators aim to ameliorate depressive symptoms among patient with Alzheimer's disease, by anodal stimulation on left dorsolateral prefrontal cortex and cathodal suppression on right supraorbital area. Active stimulation will be compare to sham condition in 20 patients (10 in each groups) from outpatient clinic in National Center of Neurology and Psychiatry, Japan.
Interventions
OTHERSham Stimulation
DEVICETranscranial Direct Current Stimulation
Sponsors
National Center of Neurology and Psychiatry, Japan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
65 Years to 90 Years
Healthy volunteers
No
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
Following potential participants will be excluded 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. In case his/her GDS score is lower than 6 at baseline 10. In case he/she is unable to agree video recording on evaluation interview
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Attrition rate due to any adverse event | three weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cornell Scale for Depression in Dementia | two weeks, three weeks, five weeks (followup) | a objective scale for depressive symptoms |
| Zarit Burden Interview | three weeks, five weeks (followup) | a subjective scale for caregivers' burden |
| Clinical Global Impression of Improvement | one, two, three and five weeks (followup) | Clinician-rated impression of improvement |
| Starkstein Apathy Scale | two, three and five weeks (followup) | a subjective scale for apathy |
| Rate of adverse events related to tDCS procedure | three weeks | — |
| Geriatric Depression Scale | one week, two weeks, three weeks, five weeks (followup) | a subjective scale for depressive symptoms |
| Neuropsychiatric Inventory | three weeks, five weeks (followup) | a objective scale for neuropsychiatric symptoms |
Other
| Measure | Time frame | Description |
|---|---|---|
| ADCS-ADL | baseline | Alzheimer's Disease Co-operative Study - Activity of Daily Living |
| Clinical Dementia Rating | baseline | severity of dementia |
| Quality of Life - Alzheimer's Disease | baseline | a QoL scale |
Countries
Japan
Outcome results
None listed