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

NCT07189754 | Completed

• 1 other identifier: OTC2020-002
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Mild Cognitive Impairment (MCI); Cognitive Dysfunction, Cognitive Disorder; Memory Problems

Keywords

Computerized Cognitive Test (COMPASS); Montreal Cognitive Assessment (MoCA); Oroxylum indicum; Cognitive Performance; Sabroxy™; Cognitive Function; Brain-Derived Neurotrophic Factor (BDNF); Memory; Attention

Outcome Measures

Primary Outcomes (3)

• Change in Montreal Cognitive Assessment (MoCA) total score

  The Montreal Cognitive Assessment (MoCA) is a 30-point interviewer-administered test assessing memory, attention, visuospatial ability, language, and executive function. Scores range from 0 to 30, with higher scores indicating better cognitive function (a score ≥26 is generally considered normal). The mean change from baseline to Week 12 will be compared between the Sabroxy™ and placebo groups.

  Baseline and Week 12

• Change in COMPASS accuracy composite (percent correct)

  The Computerized Mental Performance Assessment System (COMPASS) provides accuracy scores (% correct) across cognitive subtests (e.g., memory recognition, working memory). Composite accuracy is reported as the mean percentage correct across prespecified subtests. Scores range from 0% to 100%, with higher percentages indicating better accuracy/performance. The mean change from baseline to Week 12 will be compared between the Sabroxy™ and placebo groups.

  Baseline and Week 12

• Change in COMPASS mean reaction time (milliseconds)

  The Computerized Mental Performance Assessment System (COMPASS) measures reaction time in milliseconds (ms) across attention and response tasks. Reaction time is a continuous measure (theoretical range: 0 ms to no fixed upper limit). Lower values indicate faster and therefore better performance. Results will be reported as mean milliseconds and mean change from baseline.

  Baseline and Week 12

Secondary Outcomes (8)

• Change in Mild Cognitive Impairment Questionnaire (self-reported cognitive function) total score

  Baseline, Week 4, Week 8, Week 12

• Change in Brain-Derived Neurotrophic Factor (BDNF) Levels

  Baseline and Week 12

• Compliance with investigational product by capsule count

  Week 4, Week 8, Week 12

• Incidence of Treatment-Emergent Adverse Events (AEs)

  Baseline through Week 12

• Compliance with investigational product by daily diary review

  Week 4, Week 8, Week 12

Study Arms (2)

Sabroxy™ (Oroxylum indicum extract)

ACTIVE COMPARATOR

Consume one capsule twice daily, after a meal.

Dietary Supplement: Sabroxy™ (Oroxylum indicum extract)

Placebo (Inactive capsule)

PLACEBO COMPARATOR

Consume one capsule twice daily, after a meal.

Other: Placebo

Interventions

Sabroxy™ (Oroxylum indicum extract) DIETARY_SUPPLEMENT

Sabroxy™ is a standardized extract derived from the bark of Oroxylum indicum. In this study, participants will receive Sabroxy™ in capsule form. Each capsule contains a fixed dose of the extract and will be administered orally at a regimen of one capsule twice daily after meals for 12 weeks. The supplement is provided in visually identical containers to maintain blinding and is compared to a placebo control. The intervention is designed to evaluate potential improvements in cognitive function, including memory, attention, and executive performance, as well as effects on circulating Brain-Derived Neurotrophic Factor (BDNF) levels.

Also known as: Oroxylum indicum extract, Sabroxy™

Sabroxy™ (Oroxylum indicum extract)

Placebo OTHER

The placebo is an inert capsule formulated to be visually identical to the Sabroxy™ capsules in size, shape, color, and packaging. It contains inactive ingredients only, with no active botanical extract. The placebo will be administered orally at the same regimen as the active intervention: one capsule taken twice daily after meals for 12 weeks. The use of a placebo ensures blinding of participants and study staff, allowing accurate comparison of cognitive and biomarker outcomes between groups.

Also known as: Inactive capsule, Look-alike capsule

Placebo (Inactive capsule)

Eligibility Criteria

• Age: 60 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 that may affect cognition
• Current or recent (12 months) illicit drug abuse
• Alcohol intake \>14 drinks/week
• Significant surgery in the last year

Sponsors & Collaborators

• SF Research Institute, Inc.: lead

Study Sites (1)

San Francisco Research Institute

San Francisco, California, 94132, United States

Location

MeSH Terms

Conditions

Cognitive Dysfunction; Memory Disorders

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2025
• First Posted: September 24, 2025
• Study Start: November 2, 2020
• Primary Completion: February 8, 2021
• Study Completion: February 8, 2021
• Last Updated: September 24, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)