CompletedNot Applicable

A Study of Sabroxy™ (Oroxylum Indicum Extract) for Improving Cognitive Function in Adults With Mild Memory Concerns

United States70 participantsStarted 2020-11-02

Plain-language summary

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.

Who can participate

Age range

60 Years – 85 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Healthy adults (male and female), 60 to 85 years old 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: * Diagnosis of dementia (per NIA/AA 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…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Montreal Cognitive Assessment (MoCA) total score

Timeframe: Baseline and Week 12

Change in COMPASS accuracy composite (percent correct)

Timeframe: Baseline and Week 12

Change in COMPASS mean reaction time (milliseconds)

Timeframe: Baseline and Week 12

Trial details

NCT IDNCT07189754

SponsorSF Research Institute, Inc.

Sponsor typeNETWORK

Study typeINTERVENTIONAL

Primary completion2021-02-08

View on ClinicalTrials.gov More Mild Cognitive Impairment (MCI) trials

Plain-language summary

Who can participate

Age range

60 Years – 85 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.