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[18F]-FEOBV PET Scan for Cognitive Function in Down Syndrome

Phase 2

Recruiting

Led By Alexander C Conley, Ph.D.

Research Sponsored by Vanderbilt University Medical Center

Eligibility Criteria Checklist

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

Must have

Mental Age of 4 years or greater (based upon the Kaufman Brief Intelligence Test, 2nd Edition)

English must be first/native language

Timeline

Screening 3 weeks

Treatment Varies

Follow Up analysis will be completed at study completion in approximately 3 years.

Awards & highlights

Study Summary

This trialwill study how changes in cholinergic neurons affect adults with Down Syndrome, to inform treatments that could improve cognitive functioning.

Who is the study for?

Adults aged 18-55 with Down syndrome, including mosaic DS or partial trisomy 21, who are in good health without dementia and have a mental age of at least 4 years. Participants must not be pregnant, able to complete MRI and PET scans, and should not have significant medical conditions that could affect testing or contraindications for MRI.Check my eligibility

What is being tested?

The trial is studying the integrity of cholinergic neurons in adults with Down syndrome using [18F]-FEOBV Radiotracer. It aims to understand how these neurons' condition correlates with cognitive deficits related to aging and Alzheimer's Disease pathology.See study design

What are the potential side effects?

While specific side effects are not detailed for this study involving [18F]-FEOBV Radiotracer, typical risks may include discomfort at injection site, allergic reactions to the tracer substance used during PET scanning procedures.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My mental age is 4 years or older according to the Kaufman test.

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English is my first language.

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I have been diagnosed with Down syndrome.

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I can see and hear well enough for brain function tests.

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I am generally healthy and do not have dementia.

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I am between 18 and 55 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ analysis will be completed at study completion in approximately 3 years.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~analysis will be completed at study completion in approximately 3 years.

This trial's timeline: 3 weeks for screening, Varies for treatment, and analysis will be completed at study completion in approximately 3 years. for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

[18F]-FEOBV radiotracer standardized uptake value ratio correlation with the Basal Forebrain Cholinergic System Volume.

Secondary outcome measures

EEG resting state power correlation with [18F]-FEOBV radiotracer standardized uptake value ratio

Trial Design

1Treatment groups

Experimental Treatment

Group I: Down SyndromeExperimental Treatment1 Intervention

Adults between 18-55 with Down Syndrome.

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

Vanderbilt University Medical CenterLead Sponsor

857 Previous Clinical Trials

672,173 Total Patients Enrolled

3 Trials studying Down Syndrome

60 Patients Enrolled for Down Syndrome

Vanderbilt Kennedy CenterOTHER

2 Previous Clinical Trials

140 Total Patients Enrolled

Alexander C Conley, Ph.D.Principal InvestigatorVanderbilt University Medical Center

Media Library

Down Syndrome Clinical Trial Eligibility Overview. Trial Name: NCT05231798 — Phase 2

Down Syndrome Research Study Groups: Down Syndrome

Down Syndrome Clinical Trial 2023: Down Syndrome Highlights & Side Effects. Trial Name: NCT05231798 — Phase 2

Down Syndrome 2023 Treatment Timeline for Medical Study. Trial Name: NCT05231798 — Phase 2

Frequently Asked Questions

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

Does this research examine the participation of seniors aged 55 and up?

"This medical research is open to adults aged 18 and up, with a maximum age limit of 55."

Answered by AI

How could an individual's wellbeing be adversely affected by Down Syndrome?

"Down syndrome has been assessed to be a 2 on our safety scale, as this is Phase 2 trial and thus far only evidence of its safety has been established."

Answered by AI

How many participants have been enrolled in the clinical trial to date?

"Affirmative. The information available on clinicaltrials.gov reveals that this experiment, first posted in August of 2021, is presently recruiting individuals to participate. 20 trial participants need to be sourced from 1 medical centre."

Answered by AI

Is this experiment taking on participants at the moment?

"As per the information on clinicaltrials.gov, this medical trial is engaging participants at present. The study was initially listed on August 19th 2021 and has been amended as recently as January 31st 2023."

Answered by AI

What criteria must one meet to qualify for enrollment in this experiment?

"This clinical trial is actively seeking 20 people from 18 to 55 years old who have been diagnosed with Down syndrome. Additionally, participants must display good general health, no diagnosis of dementia and be able to understand English as a native language. Furthermore, they need to present signed informed consent forms and meet other requirements such as possessing cognitive abilities of 4 or more (assessed through the Kaufman Brief Intelligence Test) and being stable on all CNS-active medications for at least four weeks prior to enrolment in the study. For female patients, it is necessary that a negative pregnancy test be conducted within 24 hours before PET scan imaging."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Cholinergic Integrity in Down Syndrome in Association With Aging, Alzheimer's Disease Pathology, and Cognition

Alexander Christian Conley 2021. "Cholinergic Integrity in Down Syndrome in Association With Aging, Alzheimer's Disease Pathology, and Cognition". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05231798.

All > Pathology > Down Syndrome