The effects of an Oroxylum indicum extract (Sabroxy) on cognitive function in adults with mild cognitive impairment

Phase 1

Completed

• Conditions: Mild cognitive impairment; Neurological - Other neurological disorders; Alternative and Complementary Medicine - Herbal remedies

• Registration Number: ACTRN12620000800921
• Lead Sponsor: Clinical Research Australia

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-08-10
• Study Completion: 2021-02-05
• Last Update Posted: 4 April 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 82

Inclusion Criteria

1. Adults (male and female) between 60 and 85
2. Residing in independent living accommodation
3. Subjective reports of memory or cognitive impairment as measured by answering ‘yes’ to any of the following questions: (1) Do you feel your memory and thinking is getting worse? or (2) Are you concerned about your decline in memory and thinking?
4. A score between the 10th and 40th percentile for age, education, and gender on the Telephone Interview for Cognitive Status (TICS-M)
5. Non-smoker
6. BMI between 18 and 35 kg/m2
7. No plan to commence new treatments over the study period
8. Understand, willing and able to comply with all study procedures
9. Willing to provide a personally signed and dated informed consent form detailing all pertinent aspects of the trial.

Exclusion Criteria

1. Diagnosis of dementia based on the revised National Institute on Aging-Alzheimer’s Association (NIA/AA) criteria
2. Suffering from medical conditions including but not limited to: uncontrolled hypertension; myocardial infarction, unstable or severe cardiovascular disease including angina or congestive heart disease in the last year; bleeding disorders; type I diabetes; glaucoma; chronic renal failure; chronic hepatic disease; severe pulmonary disease; gastrointestinal disease requiring regular use of medications; gallbladder disease/gallstones/biliary disease; neurodegenerative or neurological disease
3. Diagnosis of significant psychiatric disorder, including schizophrenia, bipolar disorder, obsessive compulsive disorder, or personality disorder
4. A score greater than 10 on the Geriatric Depression Scale, short form (GDS-SF)
5. History of stroke, seizures, or head injury (with loss of consciousness).
6. Significant hearing loss that may impact ability to complete phone assessment
7. Regular medication intake including anti-coagulant drugs, anti-cholinergics, acetylcholinesterase inhibitors, steroid medications.
8. Change in medication in the last 3 months or expectation to change during the study duration
9. Taking vitamins or herbal supplements that are reasonably expected to influence study measures.
10. Current or 12-month history of illicit drug abuse
11. Alcohol intake greater than 14 standard drinks per week
12. Any significant surgeries over the last year

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in cognitive performance as measured by the Computerised Mental Performance Assessment System (COMPASS)[Weeks 0 and 12]

Secondary Outcome Measures

Name	Time	Method
Change in cognitive performance as measured by the Montreal Cognitive Assessment (MoCA)[Weeks 0 and 12];Change in cognitive skills as measured by the Cognitive Failures Questionnaire (CFQ)[Weeks 0, 4, 8, and 12];Change in quality of life as measured by the CASP-19[Weeks 0, 4, 8, and 12];Change in blood concentration of brain-derived neurotrophic factor (BDNF)[Weeks 0 and 12]