A Randomized, Double-Blind Placebo Controlled Study to Assess the Effects of an Oroxylum Indicum Extract (Sabroxy™) on Cognitive Function in Adults With Self-reported, Mild Cognitive Impairmentx
A Randomized, Double-Blind Placebo Controlled Study to Assess the Effects of an Oroxylum Indicum Extract (Sabroxy™) on Cognitive Function in Adults With Self-reported, Mild Cognitive Impairmentx
This study is testing whether Sabroxy™ (Oroxylum indicum extract) can improve memory and thinking in older adults who report mild problems with their cognition. The study will also measure levels of a protein in the blood called BDNF (Brain-Derived Neurotrophic Factor), which is linked to brain health.
The main questions are:
Does taking Sabroxy™ improve memory, focus, and overall cognitive performance compared to placebo (a capsule that looks the same but has no active ingredient)?
Does Sabroxy™ increase levels of BDNF in the blood?
About 80 participants between the ages of 60 and 85 will take part. All participants will be randomly assigned to receive either Sabroxy™ or placebo twice daily for 12 weeks. Neither the participants nor the researchers will know which group they are in (double-blind design).
During the study, participants will:
Take one capsule twice daily after meals.
Complete computerized cognitive tests (COMPASS), interviews with the Montreal Cognitive Assessment (MoCA), and self-assessment questionnaires on memory and thinking.
Provide blood samples to measure BDNF.
Attend 4 clinic visits (baseline, week 4, week 8, and week 12).
Keep a daily diary to track product use and study compliance.
The goal is to see whether Sabroxy™ can safely and effectively support cognitive health in older adults with mild memory concerns.
This is a randomized, double-blind, placebo-controlled clinical trial designed to evaluate the effects of Sabroxy™ (Oroxylum indicum extract) on cognitive function in adults with self-reported, mild cognitive impairment.
Approximately 84 participants will be recruited, with a goal of 80 completing the study. Participants will be between 60-85 years old, in generally good health, and living independently. Eligible participants must report concerns about their memory or thinking, confirmed with a screening test (MoCA).
After screening and baseline assessments, participants will be randomly assigned to receive either Sabroxy™ or placebo. Both products will look identical to ensure blinding. Participants will take one capsule twice daily, after meals, for 12 weeks.
The study assessments include:
Computerized Mental Performance Assessment (COMPASS): tests of memory, attention, and reaction time.
Montreal Cognitive Assessment (MoCA): an interviewer-administered cognitive test.
Mild Cognitive Impairment Questionnaire: a self-reported measure of memory and thinking concerns.
Blood samples: to measure Brain-Derived Neurotrophic Factor (BDNF) at baseline and week 12.
Daily diaries and capsule counts: to monitor adherence.
The visit schedule is as follows:
Baseline (Visit 1): Screening, informed consent, eligibility check, cognitive testing, blood draw, product distribution, and diary instructions.
Week 4 (Visit 2): Product count, diary review, questionnaire.
Week 8 (Visit 3): Product count, diary review, questionnaire.
Week 12 (Visit 4): Cognitive testing, blood draw, questionnaire, product return, diary review.
Statistical analyses will compare changes in cognitive performance and BDNF levels between the Sabroxy™ and placebo groups.
This study will provide important information about the potential of Sabroxy™ to support memory and brain health in older adults with mild cognitive concerns.
Inclusion Criteria:
Residing in independent living accommodation
Subjective reports of memory or cognitive impairment (answering "yes" to at least one of the following):
Do you feel your memory and thinking is getting worse?
Do you feel your memory and thinking has become worse over the past 2-3 years?
Are you concerned about your decline in memory and thinking?
Modified Montreal Cognitive Assessment (MoCA) score consistent with mild impairment
Non-smoker
Body Mass Index (BMI) between 18 and 35 kg/m²
No plans to commence new treatments over the study period
Understands and is willing to comply with study procedures
Provides signed and dated informed consent
Exclusion Criteria:
Uncontrolled hypertension, cardiovascular disease (MI, angina, CHF), bleeding disorders, type I diabetes, glaucoma, renal/hepatic disease, pulmonary or significant GI disease, gallbladder/biliary disease, or neurodegenerative/neurological disease
Significant psychiatric disorder (schizophrenia, bipolar disorder, OCD, personality disorder)
History of stroke, seizures, or head injury with loss of consciousness
Moderate-to-severe depression or anxiety (per Depression, Anxiety, Stress Scale)
Regular use of anticoagulants, anticholinergics, acetylcholinesterase inhibitors, or steroids
Medication change in past 3 months or expected changes during study
Use of vitamins or herbal supplements that may affect cognition
Current or recent (12 months) illicit drug abuse
Alcohol intake >14 drinks/week
Significant surgery in the last year