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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

Must not have

For participants undergoing CSF collection: a current blood clotting or bleeding disorder, or significantly abnormal PT or PTT at screening or if on anti-coagulation (e.g warfarin)

Participants unable to complete MRI and PET procedures

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have a blood clotting disorder or abnormal bleeding, and I am not on strong blood thinners like warfarin.

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I cannot undergo MRI and PET scans.

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I do not have any major health issues that could affect brain function tests.

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I have been diagnosed with dementia.

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.