Transcranial Direct Current Stimulation for Depression in Alzheimer's Disease Patient - Preliminary Research

Depression Clinical Trial

— ADAPT  

Official title:

Ameliorating Depression in Alzheimer's Disease Patients by Transcranial Direct Current Stimulation (ADAPT) - Preliminary Research

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02351388
• Other study ID #: A2014-086
• Status: Terminated
• Phase: N/A
• Start date: December 2014
• Est. completion date: March 15, 2018

Study information

• Verified date: February 2020
• Source: National Center of Neurology and Psychiatry, Japan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: March 15, 2018
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Depression
• Depressive Disorder

Intervention

Device:
• Transcranial Direct Current Stimulation

Other:
• Sham Stimulation

Locations

Country	Name	City	State
Japan	National Center of Neurology and Psychiatry	Kodaira	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
National Center of Neurology and Psychiatry, Japan

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Clinical Dementia Rating	severity of dementia	baseline
Other	Quality of Life - Alzheimer's Disease	a QoL scale	baseline
Other	ADCS-ADL	Alzheimer's Disease Co-operative Study - Activity of Daily Living	baseline
Primary	Attrition rate due to any adverse event		three weeks
Secondary	Rate of adverse events related to tDCS procedure		three weeks
Secondary	Geriatric Depression Scale	a subjective scale for depressive symptoms	one week, two weeks, three weeks, five weeks (followup)
Secondary	Cornell Scale for Depression in Dementia	a objective scale for depressive symptoms	two weeks, three weeks, five weeks (followup)
Secondary	Neuropsychiatric Inventory	a objective scale for neuropsychiatric symptoms	three weeks, five weeks (followup)
Secondary	Zarit Burden Interview	a subjective scale for caregivers' burden	three weeks, five weeks (followup)
Secondary	Clinical Global Impression of Improvement	Clinician-rated impression of improvement	one, two, three and five weeks (followup)
Secondary	Starkstein Apathy Scale	a subjective scale for apathy	two, three and five weeks (followup)

External Links

•   UMIN CTR database