UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014561 |
|---|---|
| Receipt number | R000016938 |
| Scientific Title | Ameriorating Depression in Alzheimer's disease Patients by Transcranial direct current stimulation trial - preliminary research |
| Date of disclosure of the study information | 2014/07/15 |
| Last modified on | 2018/10/08 06:38:24 |
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Basic information
Public title
Ameriorating Depression in Alzheimer's disease Patients by Transcranial direct current stimulation trial - preliminary research
Acronym
ADAPT trial - preliminary research
Scientific Title
Ameriorating Depression in Alzheimer's disease Patients by Transcranial direct current stimulation trial - preliminary research
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Yuma Yokoi |
Organization
National Center of Neurology and Psychiatry, Japan
Division name
Department of psychiatry
Zip code
Address
4-1-1, Ogawahigashi-cho, Kodaira-shi, Tokyo, Japan
TEL
042-341-2811
yyokoi@ncnp.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuma Yokoi |
Organization
National Center of Neurology and Psychiatry, Japan
Division name
Department of psychiatry
Zip code
Address
4-1-1, Ogawahigashi-cho, Kodaira-shi, Tokyo, Japan
TEL
042-341-2811
Homepage URL
yyokoi@ncnp.go.jp
Sponsor or person
Institute
National Center of Neurology and Psychiatry, Japan
Institute
Department
Personal name
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
IRB Contact (For public release)
Organization
Address
Tel
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 |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2014 | Year | 10 | Month | 14 | Day |
Date of IRB
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 |
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016938
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