Mild Cognitive Impairment (MCI)NCT07189754
A Study of Sabroxy™ (Oroxylum Indicum Extract) for Improving Cognitive Function in Adults With Mild Memory Concerns
A study testing Sabroxy™ (Oroxylum indicum extract) in people with Mild Cognitive Impairment (MCI) and Cognitive Dysfunction, Cognitive Disorder, run by SF Research Institute, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Mild Cognitive Impairment (MCI), Cognitive Dysfunction, Cognitive Disorder, Memory Problems
- What is being tested?
- Sabroxy™ (Oroxylum indicum extract)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Nov 2020to 8 Feb 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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?
Show all 12Show fewer
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
San Francisco Research Institute
San Francisco, California, 94132
About this study
Official title: A Randomized, Double-Blind Placebo Controlled Study to Assess the Effects of an Oroxylum Indicum Extract (Sabroxy™) on Cognitive Function in Adults With Self-reported, Mild Cognitive Impairmentx
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:
Read more
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.
Read the 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 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.
- Conditions
- Mild Cognitive Impairment (MCI), Cognitive Dysfunction, Cognitive Disorder, Memory Problems
- Being tested
- Sabroxy™ (Oroxylum indicum extract), Placebo
- Keywords
- Computerized Cognitive Test (COMPASS), Montreal Cognitive Assessment (MoCA), Oroxylum indicum, Cognitive Performance, Sabroxy™, Cognitive Function, Brain-Derived Neurotrophic Factor (BDNF), Memory, Attention
- Medical subject headings
- Cognitive Dysfunction, Memory Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sabroxy™ (Oroxylum indicum extract)Dietary supplement
Also called Oroxylum indicum extract, Sabroxy™
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.
PlaceboOther
Also called Inactive capsule, Look-alike capsule
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.
| Study group | Role | What they receive |
|---|---|---|
| Sabroxy™ (Oroxylum indicum extract) | Active comparator | Consume one capsule twice daily, after a meal. Receives: Dietary Supplement: Sabroxy™ (Oroxylum indicum extract) |
| Placebo (Inactive capsule) | Placebo comparator | Consume one capsule twice daily, after a meal. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Baseline and Week 12
Secondary outcomes (8)
Change in Mild Cognitive Impairment Questionnaire (self-reported cognitive function) total score
The Mild Cognitive Impairment Questionnaire is a self-report tool where participants rate memory and thinking difficulties over the past 4 weeks. Responses are recorded on a 5-point Likert scale (1 = Never, 5 = Always) across multiple items. Scores are summed to generate a total score, with the minimum possible score = [lowest possible total, e.g., number of items × 1] and maximum = [number of items × 5]. Higher scores indicate worse self-reported cognitive function (greater impairment). Mean change from baseline to Weeks 4, 8, and 12 will be compared between Sabroxy™ and placebo groups.
Measured: Baseline, Week 4, Week 8, Week 12
Change in Brain-Derived Neurotrophic Factor (BDNF) Levels
Blood samples will be collected to measure serum BDNF levels. Mean change from baseline to Week 12 will be compared between Sabroxy™ and placebo groups.
Measured: Baseline and Week 12
Compliance with investigational product by capsule count
Compliance will be assessed by counting returned capsules at each visit. Compliance percentage will be calculated as:
(number of capsules actually taken ÷ number of capsules expected to be taken) × 100(number of capsules actually taken ÷ number of capsules expected to be taken) × 100(number of capsules actually taken ÷ number of capsules expected to be taken)×100. The mean compliance percentage will be compared across groups. Unit of Measure: Percent (%)
Measured: Week 4, Week 8, Week 12
Incidence of Treatment-Emergent Adverse Events (AEs)
Safety will be assessed by recording all treatment-emergent adverse events reported or observed from baseline through Week 12. Results will be reported as the number and percentage of participants experiencing at least one AE.
Measured: Baseline through Week 12
Compliance with investigational product by daily diary review
Compliance will also be assessed by reviewing participant daily diaries documenting capsule intake. Compliance percentage will be calculated as:
(number of days capsule intake recorded ÷ number of days expected)×100(number of days capsule intake recorded ÷ number of days expected) × 100(number of days capsule intake recorded ÷ number of days expected)×100.
The mean compliance percentage will be compared across groups. Unit of Measure: Percent (%)
Measured: Week 4, Week 8, Week 12
Incidence of Serious Adverse Events (SAEs)
Serious adverse events will be recorded throughout the study. Results will be reported as the number and percentage of participants experiencing at least one SAE. Unit of Measure: Number of participants.
Measured: Baseline through Week 12
Incidence of Participant-Reported Side Effects
Tolerability will be assessed through participant-reported side effects, captured via direct questioning and diary review. Results will be reported as the number and percentage of participants reporting at least one side effect. Unit of Measure: Number of participants.
Measured: Baseline through Week 12
Number of Discontinuations Due to Adverse Events
The number of participants who discontinue the study due to adverse events will be recorded and compared between treatment groups.
Unit of Measure: Number of participants
Measured: Baseline through Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2025
- Study start2 Nov 2020
- Primary completion8 Feb 2021
- Study completion8 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive Impairment (MCI)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- SF Research Institute, Inc.
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07189754
- Sponsor's protocol ID
- OTC2020-002
- Status last verified
- Sep 2025
- First submitted
- 11 Sep 2025
- Last updated
- 24 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind Placebo Controlled Study to Assess the Effects of an Oroxylum Indicum Extract (Sabroxy™) on Cognitive Function in Adults With Self-reported, Mild Cognitive Impairmentx
- ClinicalTrials.gov ID
- NCT07189754
- Acronym / sponsor ID
- OTC2020-002
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- SF Research Institute, Inc.Research network
- Study start
- 2 Nov 2020 (actual)
- Primary completion
- 8 Feb 2021 (actual)
- Study completion
- 8 Feb 2021 (actual)
- First posted
- 24 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sabroxy™ (Oroxylum indicum extract) | Active comparator | Dietary Supplement: Sabroxy™ (Oroxylum indicum extract)Consume one capsule twice daily, after a meal. |
| Placebo (Inactive capsule) | Placebo comparator | Other: PlaceboConsume one capsule twice daily, after a meal. |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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?
Key exclusion criteria (11 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sabroxy™ (Oroxylum indicum extract)Also: Oroxylum indicum extract, Sabroxy™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. | Dietary supplement | Sabroxy™ (Oroxylum indicum extract) |
| PlaceboAlso: Inactive capsule, Look-alike capsuleThe 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. | Other | Placebo (Inactive capsule) |
Primary outcome
Change in Montreal Cognitive Assessment (MoCA) total score
Time frame: Baseline and Week 12
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.
Change in COMPASS accuracy composite (percent correct)
Time frame: Baseline and Week 12
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.
Change in COMPASS mean reaction time (milliseconds)
Time frame: Baseline and Week 12
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.
8 secondary outcomes
Change in Mild Cognitive Impairment Questionnaire (self-reported cognitive function) total score
Time frame: Baseline, Week 4, Week 8, Week 12
Change in Brain-Derived Neurotrophic Factor (BDNF) Levels
Time frame: Baseline and Week 12
Compliance with investigational product by capsule count
Time frame: Week 4, Week 8, Week 12
Incidence of Treatment-Emergent Adverse Events (AEs)
Time frame: Baseline through Week 12
Compliance with investigational product by daily diary review
Time frame: Week 4, Week 8, Week 12
Incidence of Serious Adverse Events (SAEs)
Time frame: Baseline through Week 12
Incidence of Participant-Reported Side Effects
Time frame: Baseline through Week 12
Number of Discontinuations Due to Adverse Events
Time frame: Baseline through Week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2025.
- Individual participant dataSharing planned: No
Related trials for Mild Cognitive Impairment (MCI)
RecruitingPhase 1
A First-In-Human Study of LY3954068 in Participants With Early Symptomatic Alzheimer's Disease
Alzheimer Disease
RecruitingPhase 1
PET Imaging of Phosphodiesterase-4 (PDE4) in Volunteers With Alzheimer Disease (AD) or Mild Cognitive Impairment (MCI)
Alzheimer s Disease, Mild Cognitive Impairment
Recruiting
Non-invasive Brain Stimulation for the Treatment of Mild Cognitive Impairment in Parkinson's Disease
Parkinson Disease, Mild Cognitive Impairment
RecruitingObservational study
Loneliness as Risk Factor for Dementia
Mild Cognitive Impairment (MCI), Dementia (Diagnosis)
Active, not recruiting
EFFECTS OF AN OUTDOOR MAT PILATES PROGRAM ON NEUROPHYSIOLOGICAL INDICATORS OF ELDERLY INDIVIDUALS WITH MILD COGNITIVE IMPAIRMENT
Cognition Disorders
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sabroxy™ (Oroxylum indicum extract) in people with Mild Cognitive Impairment (MCI) and Cognitive Dysfunction, Cognitive Disorder, run by SF Research Institute, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Montreal Cognitive Assessment (MoCA) total score (time frame: Baseline and Week 12). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2025.