UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Ameriorating Depression in Alzheimer's disease Patients by Transcranial direct current stimulation trial - preliminary research
Title of the study (Brief title)	ADAPT trial - preliminary research
Region	Japan

Condition
Condition	Alzheimer's disease
Classification by specialty	Psychiatry
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Depression is a quite frequent neuropsychiatric symptom among Alzheimer's disease patients though randomized controlled trials of antidepressants have failed to show their effectiveness and may have increased risk of adverse events. We focus on transcranial direct current stimulation as a novel potential treatment for depression in Alzheimer's disease and this trial will investigate its efficacy, safety and tolerability.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase I,II

Assessment
Primary outcomes	Attrition rate related to any adverse event
Key secondary outcomes	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)

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	YES
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	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
Interventions/Control_2	Sham stimulation 15 sessions in three weeks Anode site: dorsolateral prefrontal cortex Cathode site: right forehead Intensity: 2mA 30-minute sham stimulation per session
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	65 years-old <=
Age-upper limit	90 years-old >=
Gender	Male and Female
Key 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.
Key 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
Target sample size	20

Research contact person
Name of lead principal investigator	Yuma Yokoi
Organization	National Center of Neurology and Psychiatry, Japan
Division name	Department of psychiatry
Address	4-1-1, Ogawahigashi-cho, Kodaira-shi, Tokyo, Japan
TEL	042-341-2811
Email	yyokoi@ncnp.go.jp

Public contact
Name of contact person	Yuma Yokoi
Organization	National Center of Neurology and Psychiatry, Japan
Division name	Department of psychiatry
Address	4-1-1, Ogawahigashi-cho, Kodaira-shi, Tokyo, Japan
TEL	042-341-2811
Homepage URL
Email	yyokoi@ncnp.go.jp

Sponsor
Institute	National Center of Neurology and Psychiatry, Japan
Institute
Department

Funding Source
Organization	Japan Society for the Promotion of Science (JSPS)
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	none
Name of secondary funｄer(s)	none

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	国立精神・神経医療研究センター病院（東京都）

Other administrative information
Date of disclosure of the study information	2014 Year 07 Month 15 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 10 Month 14 Day
Anticipated trial start date	2014 Year 11 Month 01 Day
Last follow-up date	2017 Year 03 Month 31 Day
Date of closure to data entry	2017 Year 09 Month 30 Day
Date trial data considered complete	2017 Year 09 Month 30 Day
Date analysis concluded	2017 Year 12 Month 31 Day

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
Other related information

Management information
Registered date	2014 Year 07 Month 15 Day
Last modified on	2018 Year 10 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016938