Sabroxy® for Mild Cognitive Impairment

Overseen By Dr. John Ademola

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: SF Research Institute, Inc.

Must not be taking: Immunosuppressants, Corticosteroids

Disqualifiers: Diabetes, Cardiovascular disease, Immunosuppression, others

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if Sabroxy®, a plant extract, can improve memory and reduce insulin resistance (difficulty processing sugar) in individuals with mild cognitive issues. Participants will receive either Sabroxy® or a placebo (inactive pill) for 8 weeks to compare effects on brain function and sugar metabolism. The study seeks non-smokers who have experienced memory problems and have fasting glucose levels between 100-135 mg/dL. As an unphased trial, it offers participants the chance to contribute to groundbreaking research on natural treatments for cognitive health.

Do I need to stop taking my current medications for the trial?

You may need to stop taking certain medications, especially those that affect glucose tolerance. However, medications for chronic diseases that don't interfere with the study product might be allowed, but this will be decided by the study investigator.

Is there any evidence suggesting that Sabroxy® is likely to be safe for humans?

Research has shown that Sabroxy®, a standardized extract from the Oroxylum indicum bark, is under study for potential benefits in individuals with mild memory problems and insulin resistance. Although earlier studies have not fully detailed its safety, its progression into trials for these conditions suggests some initial confidence in its safety. Earlier findings might have indicated that it is generally well-tolerated. However, specific information on side effects or adverse reactions in humans remains limited.

Researchers will closely monitor participants in the trial for any side effects or changes in vital signs. This careful monitoring ensures that any safety concerns are promptly addressed during the study. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for mild cognitive impairment, which often include medications like cholinesterase inhibitors and lifestyle changes, Sabroxy® is a dietary supplement derived from the Indian trumpet tree. Researchers are excited about Sabroxy® because it contains oroxylin A, a compound that may enhance cognitive function by increasing levels of dopamine in the brain. This unique mechanism of action offers a novel approach to managing cognitive symptoms, potentially providing benefits that traditional medications do not. Additionally, as a natural supplement, Sabroxy® might present fewer side effects, making it an attractive option for those seeking alternative therapies.

What evidence suggests that Sabroxy® might be an effective treatment for mild cognitive impairment?

Studies have shown that Sabroxy®, a natural extract from the bark of the Oroxylum indicum tree, can improve memory and thinking skills. Research indicates that individuals taking Sabroxy® demonstrated better memory for events and performed well on tasks like immediate word recall. Additionally, Sabroxy® might help with insulin resistance, a condition where the body doesn't use insulin effectively, leading to high blood sugar. The extract also appears to reduce inflammation, which is linked to various health issues, including memory and cognitive problems. Overall, these findings suggest Sabroxy® could enhance brain function and overall health in individuals with mild memory problems. Participants in this trial will receive either Sabroxy® or a placebo to further evaluate its effectiveness. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

Adults aged 35-80 with mild cognitive impairment and insulin resistance, non-smokers, fasting glucose levels between 100-135 mg/dL, and a MoCA score below 26. Excluded are those not meeting these criteria or having conditions that could interfere with the trial.

Inclusion Criteria

In good general health

Screening fasting glucose 100 to 135 mg/dL

My MoCA score is below 26.

Exclusion Criteria

Breastfeeding, pregnant, or planning to become pregnant during the study

Currently participating in any other clinical trial

Known allergies to any ingredients in the study product

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either Sabroxy® or placebo, administered orally once daily for 8 weeks

8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Sabroxy®

Trial Overview

The trial tests Sabroxy®, an extract of Oroxylum indicum bark, against a placebo to see if it improves insulin resistance and cognitive function over 8 weeks. Participants will be randomly assigned to receive either Sabroxy® or placebo daily.

How Is the Trial Designed?

Group I: Dietary Supplement (Sabroxy®) Active Control 1 Intervention

Subjects are to take two capsules with water in the am.

Group II: Placebo (Inactive capsule) Placebo Group 1 Intervention

Subjects are to take two capsules with water in the am.

Who Is Running the Clinical Trial?

SF Research Institute, Inc.

Lead Sponsor

Trials

7

Recruited

540+

Sabinsa Corporation

Industry Sponsor

Trials

4

Recruited

120+

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8438240/

Effects of an Oroxylum indicum Extract (Sabroxy®) on ...

Oroxylum indicum was associated with greater improvements in episodic memory, and on several computer-based cognitive tasks such as immediate word recall and ...

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07189754

A Study of Sabroxy™ (Oroxylum Indicum Extract) for ...

This study is testing whether Sabroxy™ (Oroxylum indicum extract) can improve memory and thinking in older adults who report mild problems ...

3.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07220694

Effects of Sabroxy® Supplementation on Insulin ...

The intervention aims to evaluate the effects of Sabroxy® on insulin resistance, inflammation, and cognitive performance in adults with mild ...

4.

researchgate.net

researchgate.net/publication/354236968_Effects_of_an_Oroxylum_indicum_Extract_SabroxyR_on_Cognitive_Function_in_Adults_With_Self-reported_Mild_Cognitive_Impairment_A_Randomized_Double-Blind_Placebo-Controlled_Study

(PDF) Effects of an Oroxylum indicum Extract (Sabroxy® ...

Oroxylum indicum was associated with greater improvements in episodic memory, and on several computer-based cognitive tasks such as immediate word recall and ...

5.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/34531736/

Effects of an Oroxylum indicum Extract (Sabroxy®) on ...

Oroxylum indicum was associated with greater improvements in episodic memory, and on several computer-based cognitive tasks such as immediate word recall and ...

6.

patlynk.com

patlynk.com/trial/NCT07220694

Sabroxy® Supplementation for Insulin Resistance and ...

This study is focused on evaluating how a dietary supplement called Sabroxy® may help people who have mild cognitive impairment (MCI) and insulin resistance.

7.

clinicalresearch.com.au

clinicalresearch.com.au/wp-content/uploads/2020/10/Participant-Information-Sheet-Sabroxy-Cognition-Study-ver-4.pdf

Participant-Information-Sheet-Sabroxy-Cognition-Study- ...

4. Mild cognitive impairment as assessed by a validated telephone-administered cognitive assessment. 5. Non-smoker. 6. BMI between 18 and 35 kg ...