Ameriorating Depression in Alzheimer's disease Patients by Transcranial direct current stimulation trial - preliminary research

Phase 1

• Conditions: Alzheimer' s disease

• Registration Number: JPRN-UMIN000014561
• Lead Sponsor: ational Center of Neurology and Psychiatry, Japan

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-07-15
• Study Completion: 2017-03-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Attrition rate related to any adverse event

Secondary Outcome Measures

Name	Time	Method
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)