Does an extract of the plant Cosmos caudatus affect cognitive function and other health markers in older adults in Malaysia with mild cognitive impairment?

Not Applicable

Completed

• Conditions: Mild cognitive impairment; Mental and Behavioural Disorders

• Registration Number: ISRCTN16793907
• Lead Sponsor: niversiti Kebangsaan Malaysia [National University of Malaysia]

Brief Summary

2021 Results article in https://pubmed.ncbi.nlm.nih.gov/33572715/ (added 17/01/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-12-20
• Study Completion: 2019-12-21
• Last Update Posted: 30 January 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

1. Malaysian older adults aged 60-75 years at the time of informed consent
2. Mild cognitive impairment based on Petersen’s criteria:
2.1. No clinical judgment of dementia
2.2. No or very minimal limitations in Instrumental Activities of Daily Living (IADL) with a score of =1.5 SD from mean norm
2.3. Essentially preserved general cognitive functioning, with a score =19 in Mini Mental State Examination (MMSE)
2.4. Objective memory impairment, with a score of at least 1.5 SD below the mean average in one or more cognitive tests (Rey Auditory Verbal Learning Test [RAVLT] or Digit Span)
3. Able to communicate in Malay or English language
4. Body mass index (BMI) of 20-30 kg/m2

Exclusion Criteria

1. Alcohol and/or substance dependence
2. Smoker
3. Any type of neurodegenerative diseases (i.e. Parkinson disease, dementia, etc)
4. Diagnosis of a depressive disorder, schizophrenia or score >5 in Geriatric Depression Scale (GDS)
5. Any medical conditions that might interfere with the subject’s participation in the trial (i.e. uncontrolled diabetes, chronic heart disease, cancer and kidney, liver or renal failure)
6. Attention Deficit Hyperactivity Disorder (ADHD) or other conditions that might interfere with the outcomes, such as cognition function and psychosocial status
7. Regular consumer of traditional herbs, vitamin and mineral supplementation for the past 6 months, since this might jeopardize the effects of the supplement used in the study
8. Females receiving Hormone Replacement Therapy (HRT)
9. Taking medications which might be interfered with by the product (i.e. warfarin etc.)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> 1. Cognitive impairment assessed using Mini-Mental State Examination (MMSE) at baseline, week 6 and week 12<br> 2. Short-term memory assessed using Digit Span at baseline, week 6 and week 12<br> 3. Verbal memory assessed using validated Malay version of Rey Auditory Verbal Learning Test (RAVLT) at baseline, week 6 and week 12<br> 4. Processing speed assessed using the validated Digit Symbol Substitution Test (DSST) at baseline, week 6 and week 12<br> 5. Visual memory assessed using validated Visual Reproduction at baseline, week 6 and week 12<br> 6. Mood state assessed using using validated Profile of Mood state questionnaire at baseline, week 6 and week 12<br> 7. Brain activity assessed using functional magnetic resonance imaging at baseline and 12 weeks<br>