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

Phase

N/A

Condition

Memory Loss

Mild Cognitive Impairment

Dementia

Treatment

Sabroxy™ (Oroxylum indicum extract)

Placebo

Clinical Study ID

NCT07189754

OTC2020-002

Ages 60-85
All Genders
Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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

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 that may affect cognition

Current or recent (12 months) illicit drug abuse

Alcohol intake >14 drinks/week

Significant surgery in the last year

Study Design

Sabroxy™ (Oroxylum indicum extract)

November 02, 2020

February 08, 2021

Study Description

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.

Connect with a study center

San Francisco Research Institute
San Francisco 5391959, California 5332921 94132
United States
Site Not Available

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