Verification of safety and efficacy of plasmalogen and elastin combined formulation in cognitive function

JRCT ID: jRCTs041210012

Registered date:23/04/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: subarachnoid hemorrhage, cerebral infarction, cerebral hemorrhage,
• Date of first enrollment: 07/06/2021
• Target sample size: 189
• Study type: Interventional
• Intervention(s): To evaluate cognitive function improvement effect of combined formulation of plasmalogens and elastin containing food for forgetful and dementia preliminary forces

Outcome(s)

• Primary Outcome: Japanese version of River Mead Behavior Memory Test
• Secondary Outcome: Clinical Assessment for Attention-Visual Cancellation Task, MOS 36-Item Short-Form Health Survey, AGE Reader-Advanced Glycation End-products,

Key inclusion & exclusion criteria

• Age minimum: >= 65age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1) The subjects who are Male and Femaile over 65 who are aware of forgetfulness.
2) The subjects who displayed 24 scores or more of MMSE-J

Exclude criteria

1) The subjects who are likely to have allergy symptoms due to test ingredients.
2) The subjects who were diagnosed as patients with dementia
3) The subjects who received surgical operation for stroke, subarachnoid hemorrhage, cerebral infarction, cerebral hemorrhage, cerebral contusion injury Head trauma Those with the inpatient surgery.
4) The subjects with medical history of epilepsy or diabetes and/or receiving medical treatment presently.
5) The subjects who is taking medicines (antipsychotic drugs, anxiolytics, antidepressants, antiparkinsonian drugs, antidepressants, antiepileptic drugs

Related Information

• Primary Sponsor: Ono Ken
• Secondary Sponsor: Yamada Shizuo,Sansho Pharmaceutical Co., Ltd.,HAGOROMO FOOS CORPORATION.