None listed
Conditions
Brief summary
In this randomised, double-blind, placebo-controlled study, 80 adults with mild cognitive impairment will be randomly assigned to receive capsules containing either an Oroxylum indicum extract (1000 mg a day) or placebo for 12 weeks. A computer-based assessment and several validated clinician-administered and self-report measures (to be completed at various time points throughout the study) will be administered to assess change in cognitive performance and quality of life. We will also examine changes in blood concentrations of brain-derived neurotrophic factor (BDNF).
Interventions
Condition 1: Placebo capsules (1 capsule taken orally, twice daily after food at breakfast and dinner times for 12 weeks)
Condition 2: Oroxylum indicum extract (Sabroxy) (1 capsule taken orally, twice daily after food at breakfast and dinner times, delivering 1000mg a day, for 12 weeks)
Adherence to capsule intake will be monitored through capsule return and count.
Sponsors
Clinical Research Australia
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
60 Years to 85 Years
Healthy volunteers
No
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
Outcome results
None listed