Clinical trial NCT02351388: Transcranial Direct Current Stimulation for Depression in Alzheimer's Disease Patient - Preliminary Research
Official title: Ameliorating Depression in Alzheimer's Disease Patients by Transcranial Direct Current Stimulation (ADAPT) - Preliminary Research
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Alzheimer Disease
Depression
Keywords: Alzheimer's disease
Depressive symptoms
Neuropsychiatric symptoms
Behavioral and Psychological Symptoms of Dementia
Neuromodulation
Transcranial Direct Current Stimulation
Lead sponsor: National Center of Neurology and Psychiatry, Japan
Sponsor class: OTHER
First posted: 2015-01-30
Enrollment: 4
Sex: ALL
Minimum age (years): 65
Maximum age (years): 90
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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: 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

Primary outcomes:
measure: Attrition rate due to any adverse event
timeFrame: three weeks
Secondary outcomes:
measure: Rate of adverse events related to tDCS procedure
timeFrame: three weeks
measure: Geriatric Depression Scale
timeFrame: one week, two weeks, three weeks, five weeks (followup)
measure: Cornell Scale for Depression in Dementia
timeFrame: two weeks, three weeks, five weeks (followup)
measure: Neuropsychiatric Inventory
timeFrame: three weeks, five weeks (followup)
measure: Zarit Burden Interview
timeFrame: three weeks, five weeks (followup)
measure: Clinical Global Impression of Improvement
timeFrame: one, two, three and five weeks (followup)
measure: Starkstein Apathy Scale
timeFrame: two, three and five weeks (followup)
Other outcomes:
measure: Clinical Dementia Rating
timeFrame: baseline
measure: Quality of Life - Alzheimer's Disease
timeFrame: baseline
measure: ADCS-ADL
timeFrame: baseline
Locations:
city: Kodaira
country: Japan
facility: National Center of Neurology and Psychiatry
state: Tokyo
Study officials:
affiliation: National Center of Neurology and Psychiatry, Japan
name: Yuma Yokoi, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Narita Z, Yokoi Y. Transcranial direct current stimulation for depression in Alzheimer's disease: study protocol for a randomized controlled trial. Trials. 2017 Jun 19;18(1):285. doi: 10.1186/s13063-017-2019-z.