The efficacy of ferulic acid and Angelica archangelica extract on patients with mild Alzheimer's dementia
- Conditions
- Alzheimer's dementiaAlzheimer's disease dementiaD000544
- Registration Number
- JPRN-jRCTs031220615
- Lead Sponsor
- So Mirai
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 320
(1) Currently attending Tokyo Dental University Ichikawa General Hospital or other hospital
(2) Meeting the NIAA diagnostic criteria for probable AD, with the following indications of mild AD:
Indications of mild AD
1. MMSE-J score of 23 or less
2. Clinical Dementia Rating-Japanese (CDR-J) of 0.5 or 1
3. Stage 4 (mild) or lower on the Functional Assessment Staging of Alzheimer Disease (FAST)
4. Education level of at least 9 years
5. Memory criteria: Delayed recall of one paragraph of the Wechsler Memory Scale-Revised Logical Memory II subscale with the cut-off scores according to years of education
(3) Taking Donepezil hydrochloride 5mg per day for at least 1 month prior to the start of the study
(4) Both subject and legal representative capable of giving informed consent in writing
(5) Native Japanese speakers with normal writing ability and no significant audio-visual impairment that would interfere with the evaluation (Abnormalities in writing ability due to neurodegenerative diseases are acceptable)
(6) No serious illness or hospitalization interrupting this study
(8) No abnormalities in their medical history, physical examination, or general blood test findings that would interfere with the study
(9) Attending the study on the designated date with a capability of undergoing the necessary examinations and treatment
1) Any history of substance-related disorders, such as alcohol or drugs as defined by the DSM-5, within the past 2 years that has affected cognitive function.
2) Suffering from depression or bipolar disorder as defined by the DSM-5 within the past year.
3) A history of schizophrenia as defined by the DSM-5
4) Depressive sate (GDS-S-J score of 11 or higher)
5) Huntington's disease, multiple cerebral infarction, normal pressure hydrocephalus, brain tumour, epilepsy, seizure disorder, subdural hematoma, multiple sclerosis, etc.
6) Early-onset AD
7) Diseases other than AD that affect cognitive function, such as infections or focal lesions such as cortical cerebral infarction
8) Vitamin B12 deficiency, syphilis, or abnormalities in thyroid function that affect cognitive function.
9) Psychiatric symptoms, excitability, or behavioural abnormalities within the past 3 months that would make it difficult to comply with the research plan.
10) Other psychiatric or neurological disorders that would significantly interfere with the performance of this research.
11)Serious systemic diseases, severe hepatic disorder, renal disorder, or circulatory disorder.
12)Any history of serious food or drug allergies such as anaphylactic shock.
13)Currently taking more than 5 mg of donepezil hydrochloride
14) Using drugs other than donepezil hydrochloride that affect cognitive function, such as anti-dementia drugs.
15) Currently or within the past 6 months participating in any clinical trial of drugs or medical devices, or scheduled to participate in any clinical trial of other Alzheimer's disease drugs during the period of this study
16) Taking antipsychotic, antidepressant, or antiepileptic drugs
17) Taking anti-anxiety medications for purposes other than sleep treatment.
18) Judged by the principal investigator (or co-investigator) to be inappropriate to participate in this study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percent change from baseline in Alzheimer Disease Assessment Scale-Cognitive Component-13 Japanese version ([value after 48 weeks of treatment - value before the start of treatment (0 week)]/value before the start of treatment (0 week) *100)
- Secondary Outcome Measures
Name Time Method (1)Alzheimer Disease Assessment Scale-Cognitive Component-13 Japanese version<br>(2)iADRS(Integrated Alzheimer Disease Rating Scale)<br>(3)ADCS-iADL(Alzheimer's Disease Cooperative Study-Instrumental Activities of Daily Living Inventory<br>(4)MMSE-J(Mini Mental State Examination-Japanese)<br>(5)EQ-5D-5L(EuroQol 5 dimensions 5-level)<br>(6)SDISS(Sheehan Disability Scale)<br>(7)OSIT-J(Odor Stick Identification Test for Japanese)<br>(8)Amyloid beta 42/40 ratio<br>(9)2-minute voice recording