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New treatment option for Down Syndrome
Official title Cholinergic Integrity in Down Syndrome in Association With Aging, Alzheimer's Disease Pathology, and Cognition
ClinicalTrials.gov ID: NCT05231798
What this study is testing
What is [18F]-FEOBV Radiotracer?
[18F]-FEOBV Radiotracer is an investigational medicine, given as a treatment applied to the skin, being studied as a potential treatment for down syndrome.
Also referred to as [18F]-fluoroethoxybenzovesamicol.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Progressive age-related cognitive deficits occurring in both AD and DS have been connected to the degeneration of several neuronal populations, but mechanisms are not fully elucidated. The most consistent neuronal losses throughout the progression of AD are seen in cholinergic neurons where these losses negatively affect cognition, particularly in attention, learning, and memory formation.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 55. Healthy volunteers may be eligible.
You may be able to join if
- Diagnosis of Down syndrome (DS), including mosaic DS or partial trisomy 21.
- Provision of signed and dated informed consent form and if needed, assent with signed consent by a legally authorized representative (LAR).
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or female, aged 18-55 inclusive.
- In good general health as evidenced by medical history with no diagnosis of dementia.
You likely can't join if
- Any significant disease or unstable medical condition that could affect neuropsychological testing (i.e., unstable cardiac problems, chronic renal...
- Participants in whom magnetic resonance imaging (MRI) is contraindicated including, but not limited to, those with a pacemaker, presence of metallic...
- Participants unable to complete MRI and PET procedures
- IQ less than 40 (as assessed by Kaufman Brief Intelligence Test, Second Edition (KBIT-2).
- Pregnancy, breast-feeding
- History within the last 5 years of a primary or recurrent malignant disease with the exception of non-melanoma skin cancers, resected cutaneous...
See the full eligibility criteria
- Diagnosis of Down syndrome (DS), including mosaic DS or partial trisomy 21.
- Provision of signed and dated informed consent form and if needed, assent with signed consent by a legally authorized representative (LAR).
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or female, aged 18-55 inclusive.
- In good general health as evidenced by medical history with no diagnosis of dementia.
- Permitted CNS-active medications, stable in dose for at least 4 weeks or longer. If new medications have been started, the medical monitoring team will review on case-by-case basis to recommend timing of baseline...
- Adequate visual and auditory acuity to allow neuropsychological testing
- For females who are not surgically sterile or post-menopausal by two years: negative pregnancy test 24 hours prior to PET scan.
- Mental Age of 4 years or greater (based upon the Kaufman Brief Intelligence Test, 2nd Edition)
- English must be first/native language
- Reliable Study Partner (may be caregiver, sibling, parent) who can provide information about the subject's clinical symptoms and history
- Any significant disease or unstable medical condition that could affect neuropsychological testing (i.e., unstable cardiac problems, chronic renal failure, chronic hepatic disease, severe pulmonary disease)
- Participants in whom magnetic resonance imaging (MRI) is contraindicated including, but not limited to, those with a pacemaker, presence of metallic fragments near the eyes or spinal cord, or cochlear implant (Dental...
- Participants unable to complete MRI and PET procedures
- IQ less than 40 (as assessed by Kaufman Brief Intelligence Test, Second Edition (KBIT-2).
- Pregnancy, breast-feeding
- History within the last 5 years of a primary or recurrent malignant disease with the exception of non-melanoma skin cancers, resected cutaneous squamous cell carcinoma in situ, basal cell carcinoma, cervical carcinoma...
- Clinically significant abnormalities in B12 or TFTs that might interfere with the study. A low B12 is exclusionary unless follow-up labs (homocysteine (HC) and methylmalonic acid (MMA)) indicate that it is not...
- Clinically significant abnormalities in screening laboratories
- 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 whom the Site PI deems to be otherwise ineligible
- Clinical diagnosis of dementia
- Concurrent participation in a clinical trial for an investigational product or concurrent participation in a longitudinal study with overlapping outcome measures/procedures is prohibited
The study team makes the final eligibility decision.
Where it's taking place
- Nashville, Tennessee, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 55 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nashville, Tennessee, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.