Status:
COMPLETED
A Study of Sabroxy™ (Oroxylum Indicum Extract) for Improving Cognitive Function in Adults With Mild Memory Concerns
Lead Sponsor:
SF Research Institute, Inc.
Conditions:
Mild Cognitive Impairment (MCI)
Cognitive Dysfunction, Cognitive Disorder
Eligibility:
All Genders
60-85 years
Phase:
NA
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...
Detailed 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 c...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 2 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 8 2021
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT07189754
Start Date
November 2 2020
End Date
February 8 2021
Last Update
September 24 2025
Active Locations (1)
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1
San Francisco Research Institute
San Francisco, California, United States, 94132