Clin-Syn: Understanding Biomarkers in Lewy Body Dementia and Alzheimer’s Disease

Many people with Lewy body dementia and Alzheimer’s disease have similar symptoms, especially in the early stages. This can make it hard for doctors to know exactly what is causing a person’s memory, thinking or movement problems.

The Clin-Syn study aims to learn more about biological changes in the body to help doctors better identify and understand these diseases, particularly in the early stages. This is important to help guide diagnosis and care, including developing new treatments for these diseases.

What is This Study About?

Researchers are studying several different tests, called biomarkers, that may help identify signs of Lewy body dementia and Alzheimer’s disease. Biomarkers can come from blood, spinal fluid, skin samples, brain scans and other tests.

Researchers want to learn:

• Which biomarkers work best for detecting Lewy body disease and Alzheimer’s.
• How these biomarkers relate to symptoms such as memory changes, movement problems, sleep issues and thinking changes.
• How complicated biomarker test results can be shared with families in a helpful way

The information collected will help researchers better understand these diseases and may improve diagnosis and future treatments.

What is Involved?

Most study activities occur during one comprehensive visit, although procedures may be scheduled across multiple days based on participant preference and scheduling needs.

Participants will:

• Complete memory, thinking and health assessments.
• Provide blood, nasal swab and saliva samples.
• Have a lumbar puncture (also called a spinal tap) to collect spinal fluid.
• Have small skin biopsies.
• Complete brain imaging (a brain MRI and a DaTscan).

Additional Details

Duration: Participants will complete the study over one or several visits, depending on scheduling and personal preference.
Format: In-person with a study partner (required). This is someone who is in frequent contact with you, knows your day-to-day abilities well, and can come to visits.
Results: Participants will have the option to receive clinical testing results in follow-up visits.

Who can Participate?

You may be eligible to participate if you:

• Are 50 years of age or older.
• Speak English or Spanish.
• Are willing to undergo a lumbar puncture, skin biopsy, MRI and DaTscan.
• Have a study partner who can provide information about symptoms and daily functioning.
• Meet criteria for one of the following groups:
  • • Mild cognitive impairment due to suspected Lewy body disease or mild dementia with Lewy bodies,
    • Mild cognitive impairment due to Alzheimer’s or mild Alzheimer’s dementia,
    • Cognitively unimpaired adults serving as comparison participants.

Exclusion Criteria

Certain medical conditions, medications or safety concerns may make a person ineligible to participate.
Study staff will review eligibility requirements and study procedures in more detail with interested individuals.

Study Sites

San Francisco. California
University of California San Francisco
PI: Luke Fischer, MD, PhD
Site Coordinator: Salma Rocha
LewyReferrals@ucsf.edu

Gainesville, Florida
University of Florida
PI: Breton Asken, PhD
Site Coordinator: Alesa Flewellen
alesa.willis@phhp.ufl.edu

San Antonio, Texas
UT Health San Antonio
PI: Jeremy Tanner, MD
Site Coordinator: Iveliz Sanchez-Cruz
Clin-Syn@UTHealthSA.org

Richmond, Virginia
Virginia Commonwealth University
PI: Matthew Barrett, MD
Site Coordinator: Kara McHaney
kara.mchaney@vcuhealth.org

Study Funder/Sponsor

The Clin-Syn study is funded by the Lewy Body Dementia Association. Learn more at LBDA.org>>

Meet Your Clinical Research Team

April K. Boreham, MA, MBA, LPA

Jeremy Tanner, MD