Yam extract study for dementia

JRCT ID: jRCTs041200036

Registered date:21/07/2020

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Mild cognitive impairment and mild Alzheimer's d isease
• Date of first enrollment: 16/12/2020
• Target sample size: 50
• Study type: Interventional
• Intervention(s): Intake of Yam extract

Outcome(s)

Primary Outcome

1) MMSE
2) ADAS-cog

Secondary Outcome

1) Level of NF-L in plasma
2) Level of Abeta42 and Abeta40 in plasma for Abeta42/40 ratio
3) Level of GFAP in plasma

Key inclusion & exclusion criteria

• Age minimum: >= 40age old
• Age maximum: <= 85age old
• Gender: Both

Include criteria

1) Those whose age at consent date is 40 years - 85 years.
2) Those who can participate in the inspection performed at the University of Toyama Sugitani campus.
3) Those who meet the criteria for mild cog nitive impairment or mild Alzheimer's disease according
to DSM-5. For patients with mild Alzheimer's disease, those who are taking only cholinesterase inhibitors.
4) Those who have MMSE score of 20 or more at the time of screening .
5) Those who ag ree to provide blood samples for clinical tests.
6) The person can take the test drug , and the person or family can manag e the medication of the test drug.
7) Those who agree not to take commercially available yam extract products during the test period.
8) Those who ag ree not to make any extreme chang es in lifestyle habits such as exercise and eating habits during the test period.

Exclude criteria

1) Patients in the neurodevelopmental disorder, schizophrenia spectrum disorder and other psychotic disorders, bipolar disorder and related disorders, eating behavior disorder and eating disorder, personality disorder group.
2) Those who was in uncontrolled and clinically problematic health conditions (diabetes, hypertension, thyroid / endocrine disorders, cong estive heart failure, angina, heart disease, cancer risk such as breast cancer, uterine cancer, or ovarian cancer, gastrointestinal disease, dialysis or renal dysfunction, etc.) within 3 months of consent.
3) Those who have a history of alcohol and substance abuse
4) Those who have a history of yam allergy
5) Those who are participating in other invention clinical trials
6) Any other person who is judged to be inappropriate as a subject by the researcher

Related Information

• Primary Sponsor: Suzuki Michio
• Secondary Sponsor: Tohda Chihiro