Effect of PM-EE on the Mild cognitive decline for the Efficacy and Safety; A 12week, Randomized, Double-blind, Placebo-Controlled Clinical Trial

Effect of PM-EE on the Mild Cognitive Impairment for the Efficacy and Safety; A 12week, Randomized, Double-blind, Placebo-Controlled Clinical Trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0003418

Enrollment

Registered

2019-01-10

Start date

2018-03-08

Completion date

Unknown

Last updated

2019-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Dietary Supplement : Eeah group takes either placebo or PM-EE(SE-EE) 2 tablets by mouth twice daily for 12 weeks. The shape and weight of placebo or PM-EE(SE-EE) are same.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Having complaint of memory loss in aged 55~85 years 2) Literate 3) Korean version of the consortium to establish a Registry for Alzheimer’s Disease(CERAD-K) Word list memory or Word delayed recall or Word recognition is decreased 1.0SD ~ 1.5SD 4) Agree to Informed consent

Exclusion criteria

Exclusion criteria: Having history of 1) malignant tumor or severe cerebrovascular disease or severe heart disease 2) schizophrenia 3) major depressive disorder according to DSM-V(The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition) 4) cognitive disorder based on DSM-V (e.g. dementia, Parkinson's disease, cerebral infarction) 5) in 4 weeks prior to this study, the medication related to congnitive disorder intake 6) Vitamin E over 400 IU contained drug intake 7) in 2 months prior to this study, Estrogen replacement therapy was received 8) in 2 weeks prior to this study, the dietary supplement related to enhance congnitive function intake 9) alcohol abuse 10) thyroid stimulation hormon (TSH) was decreased under 0.1 uIU/ml or increased over 10 uIU/ml 11) creatinine level was increased over two times of the upper limit 12) AST(GOT) and/or ALT(GPT) was increased over three times of the upper limit 13) uncontrolled hypertension 14) uncontrolled DM 15) In 3 months prior or after this study, involvement to other clinical trial 16) being determined to be inappropriate

Design outcomes

Primary

Measure	Time frame
change of total score of ADAS-cog(Cognitive subscale of the ADAS) from baseline to 12 weeks later	—

Secondary

Measure	Time frame
change of memory of ADAS-cog(Cognitive subscale of the ADAS) from baseline to 12 weeks later;change of total score of ADAS-K(Alzheimer’s Disease Assessment Scale-Korean version) from baseline to 12 weeks later;change of the score of K-CWST(Korean-Color Word Stroop Test) from baseline to 12 weeks later;change of total score of SGDS(Short form of Geriatric Depression Scale) from baseline to 12 weeks later;change of total score of ADCS-ADL(Alzheimer’s Disease Cooperative Study-Activities of Daily Living) from baseline to 12 weeks later	—

Measure

Time frame

change of memory of ADAS-cog(Cognitive subscale of the ADAS) from baseline to 12 weeks later;change of total score of ADAS-K(Alzheimer’s Disease Assessment Scale-Korean version) from baseline to 12 weeks later;change of the score of K-CWST(Korean-Color Word Stroop Test) from baseline to 12 weeks later;change of total score of SGDS(Short form of Geriatric Depression Scale) from baseline to 12 weeks later;change of total score of ADCS-ADL(Alzheimer’s Disease Cooperative Study-Activities of Daily Living) from baseline to 12 weeks later

—

Countries

Korea, Republic of

Contacts

Public ContactJIYOUNG SHIM

Seoul National University Hospital

neuro_snuh@naver.com+82-2-2072-2193

Outcome results