What side effects are associated with this type of intervention?

Common treatments for Down Syndrome include early intervention programs, educational support, and medical management of associated conditions such as heart defects, thyroid disorders, and vision problems. Non-invasive imaging techniques like Optical Coherence Tomography (OCT) and OCT Angiography (OCTA) are used to assess retinal and choroidal microvasculature, primarily to monitor eye health. These imaging techniques are generally safe and well-tolerated, with minimal side effects, primarily limited to mild discomfort or light sensitivity during the procedure. Broader treatments for Down Syndrome may have side effects related to specific medications or therapies used to manage associated conditions, such as gastrointestinal issues from thyroid medications or potential surgical risks from corrective heart surgeries.

What other types of research exist?

A promising novel alternative to OCT and OCTA for assessing retinal and choroidal microvasculature in Down Syndrome patients is ultra-widefield (UWF) fundus photography. This technology allows for a comprehensive view of the retina and choroid, which can be beneficial for detailed assessment and monitoring.

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Retinal Imaging for Neurodegenerative Disease

Q: What prior FDA approvals exist?

There are no specific FDA-approved treatments for Down Syndrome mentioned in the provided context. Additionally, there is no mention of treatments related to non-invasive imaging techniques like Optical Coherence Tomography (OCT) and OCT Angiography (OCTA) for Down Syndrome. Generally, treatment for Down Syndrome focuses on managing individual symptoms and associated medical conditions rather than a specific FDA-approved drug for the syndrome itself.

N/A

Recruiting

Led By Sharon Sharon, MD FACS FASRS

Research Sponsored by Duke University

Eligibility Criteria Checklist

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

Must have

Patients with neurodegenerative disease (MCI/ADPD/MS/HD)

Be older than 18 years old

Must not have

Eyes that have had intraocular surgery, other than cataract surgery

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial uses special cameras to take detailed pictures of the back of the eye in people with cognitive impairments or neurodegenerative diseases. Researchers analyze these images to find early signs of these diseases by examining tiny blood vessels in the eye.

Who is the study for?

This trial is for adults with or without neurodegenerative diseases like Alzheimer's, Parkinson's, Multiple Sclerosis, and others. It includes those with mild cognitive issues or traumatic brain injuries. People can't join if they've had certain eye surgeries (except cataract surgery) or have conditions that make it hard to get clear images of their eyes.

What is being tested?

The study tests non-invasive imaging techniques to examine the retina and choroid in the eye. These include optical coherence tomography (OCT), OCT angiography (OCTA), and ultra-widefield fundus photography to find biomarkers for various neurodegenerative diseases.

What are the potential side effects?

Since this trial involves non-invasive retinal imaging, there are minimal side effects expected. The main risks may include discomfort from bright lights during imaging or temporary vision disturbances after the procedures.

Eligibility Criteria

Inclusion Criteria

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

Select...

I have a neurodegenerative condition like Alzheimer's or Parkinson's.

Exclusion Criteria

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

Select...

I have had eye surgery, but not for cataracts.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in average capillary flux index (CFI)

Change in average capillary perfusion density (CPD)

Change in average perfusion density (PD)

+6 more

Secondary study objectives

Change in retinal vessel fractal dimension

Change in retinal vessel tortuosity

Change in retinal vessel width gradient

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: ControlsExperimental Treatment1 Intervention

Controls will be recruited from the relatives/attendants of study participants or will be patients themselves and will not have a neurodegenerative disease diagnosis.

Group II: CaseExperimental Treatment1 Intervention

Patients with (MCI, PD, AD, FTD, DLB, ALS, MS, HD, TBI, concussion, PTSD and other neurodegenerations as well as Down Syndrome)

0 / 2Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Down Syndrome primarily focus on managing the symptoms and associated health conditions rather than altering the genetic basis of the disorder. These treatments include early intervention programs, speech therapy, physical therapy, and occupational therapy, which aim to improve cognitive and motor skills. Medical treatments may address specific health issues such as heart defects, thyroid problems, and hearing loss. Non-invasive imaging techniques like Optical Coherence Tomography (OCT) and OCT Angiography (OCTA) are particularly important for Down Syndrome patients as they can help monitor and manage ocular complications, such as cataracts and retinal issues, without the need for invasive procedures. These imaging methods provide detailed views of the retinal and choroidal microvasculature, aiding in early detection and treatment of potential vision problems, thereby improving the quality of life for individuals with Down Syndrome.