Exploratory research of rTMS in Alzheimer's disease

JRCT ID: jRCTs052180226

Registered date:30/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Alzheimer's disease
• Date of first enrollment: 28/04/2019
• Target sample size: 42
• Study type: Interventional
• Intervention(s): rTMS(repetitive transcranial magnetic stimulation)

Outcome(s)

• Primary Outcome: Amount of change from the value after the last intervention to the pre-intervention

Secondary Outcome

1.MMSE
The changing rate after the last intervention relative to the pre-intervention
The percentage of the number of subjects who improved the value immediately after the last intervention with respect to the pre-intervention value by 3 points or more
2.ADAS-cog
The changing value and changing rate after the last intervention relative to the pre-intervention
The percentage of the number of subjects who improved the value immediately after the last intervention with respect to the pre-intervention value by 3 points or more
3.MoCA-J
The changing value and changing rate after the last intervention relative to the pre-intervention
4.CDR-J
The changing value of SUM OF BOXES after the last intervention relative to the pre-intervention
The percentage of the number of subjects who improved the value immediately after the last intervention with respect to the pre-intervention value by 1 points or more
5.NPI
The changing value after the last intervention relative to the pre-intervention
6.EQ-5D-5L
The changing value and changing rate after the last intervention relative to the pre-intervention
7.CGIC
The number and percentage of 1, 2 or 3 after the intervention
8.MMSE memory items Immediate Recall, Delayed Reproduction and Repeat
The changing value and changing rate after the last intervention relative to the pre-intervention
The percentage of the number of subjects who improved the value immediately after the last intervention with respect to the pre-intervention value by 2 points or more
9.electroencephalography
The changing value the ratio of alpha wave and beta wave,
after intervention to the pre-intervention
10.adverse effects
diagnosis name, onset time of illness , disappearance time, frequency, disease severity, the causation, an outcome and severity

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1. Diagnosis criteria from NINCDSADRDA Work Group: probable AD
2. MMSE: less than or equal to 25
3. CDR-J:1 or 2
4.The cognitive function control is insufficient though received medical therapy more than 6 months, or received medical therapy more than 6 months in the past
5.Age of the acquired the agreement: 20 years old or older
6.Written informed consents or informed assent, which the person and proxies such as families as well as a patient acquired the agreement, are obtained

Exclude criteria

1.Severe dementia MMSE: less than or equal to 9
2.Severe psychiatric disorder
3.Past medical history epilepsy
4.drug abuse or dependence, including alcoholism
5.with a desire for suicide
6.Pregnant and Wishing to get Pregnant
7.having heart pacemaker or drug infusion pomp
8.having the deep brain stimulation or the spinal cord stimulation
9.with an implanted metal, except for titanium products, in their heads
10.considered unsuitable for this clinical trial by a principal or sub investigator
11.Judged as inappropriate for this study by doctors

Related Information

• Primary Sponsor: Saitoh Youichi
• Source(s) of Monetary Support: TEIJIN PHARMA LIMITED,Japan Agency for Medical Research and Development