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Souvenaid for Cognitive Decline

Phase 2

Waitlist Available

Led By Christian Camargo, MD

Research Sponsored by University of Miami

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

Study Summary

This trial will investigate whether a daily multinutrient supplement can improve cognition and quality of life in older adults.

Eligible Conditions

Cognitive Decline

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Overall feasibility of this study will be assessed

Successful Retention rate

Successful adherence to the intervention

+2 more

Secondary outcome measures

Digit Span (WAIS-IV)

Matrix reasoning from the Test My Brain (TMB) research battery

Rey Auditory Verbal Learning Task (RAVLT) or WHO/UCLA Auditory Verbal Learning Task (AVLT)

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Treatment GroupExperimental Treatment1 Intervention

Participants in the treatment group will receive 125 mL of Souvenaid taken by mouth, once daily, for 6 consecutive months.

Group II: Placebo GroupPlacebo Group1 Intervention

Participants in the treatment group will receive 125 mL of iso-caloric placebo taken by mouth, once daily, for 6 consecutive months.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Souvenaid

2021

Completed Phase 2

~70

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of MiamiLead Sponsor

898 Previous Clinical Trials

409,584 Total Patients Enrolled

2 Trials studying Cognitive Decline

70 Patients Enrolled for Cognitive Decline

American Academy of NeurologyOTHER

11 Previous Clinical Trials

275 Total Patients Enrolled

Christian Camargo, MDPrincipal Investigator - University of Miami

University of Miami Hospital

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the FDA sanction Souvenaid for therapeutic use?

"While Phase 2 trials offer less data regarding a medication's efficacy, there is still some evidence to support Souvenaid's safety. Consequently, our team at Power has given it a score of 2."

Answered by AI

Are new patients still being sought for this clinical trial?

"Yes, the trial is still open for recruitment according to the latest information on clinicaltrials.gov. This particular study was first posted on 6/4/2021 and was updated as recently as 5/18/2022. They are looking for 60 participants from 1 site."

Answered by AI

Are young adults within the age bracket of this research?

"As this clinical trial's eligibility requirements state, prospective participants must be aged 55 to 89."

Answered by AI

How many participants are required for this research project?

"That is accurate. According to information available on clinicaltrials.gov, this trial began recruiting on 6/4/2021 and is still looking for 60 individuals across 1 site."

Answered by AI

To whom is this research opportunity available?

"This clinical trial is seeking 60 individuals aged 55-89 who have cognitive decline. Participants must meet the following criteria: A) A score of >85th percentile on the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)., and B) Subjective Cognitive Decline (SCD) 9-item brief screening tool score within the 25th percentile (SCD =1) and 75th percentile (SCD = 6), C) Participants will additionally be expected to score in the normal range of MoCA, defined in this study as greater than 24/30., Age 55-89, Written informed consent"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Reducing the Effects of Aging on Cognition With Therapeutic Intervention of an Oral Nutrient (REACTION): A Pilot Trial

Christian Camargo 2021. "Reducing the Effects of Aging on Cognition With Therapeutic Intervention of an Oral Nutrient (REACTION): A Pilot Trial". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04147624.