Purpose

We are seeking adults with Down Syndrome without any signs or symptoms of dementia to gather information needed for the development of future clinical trials on Alzheimer’s Disease in the Down Syndrome population.  Individuals enrolled will undergo neuropsychological testing, imaging studies, and have blood and urine samples collected for clinical and genetic studies. 

Category

IRB Number
20220340HU
NCT Number
NCT04165109
Open to Enrollment
Sponsor
University of Southern California -



Study Contact

Floyd Jones
+1 (210) 450-3158
jonesfa@uthscsa.edu

Principal Investigator
Sarah Savoia

Floyd Jones
+1 (210) 450-3158
jonesfa@uthscsa.edu



Eligibility

Eligible Ages
25-55
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

    1) Mental age of 4 years or greater; 2) Have a reliable study partner (caregiver, sibling, parent etc.) who can accompany participant to visits and provide information about their medical symptoms and history; 3) Must be able to speak English or Spanish fluently ​​​​​​​

Exclusion Criteria

    1) Unable or unwilling to undergo an MRI or PET scan; 2) If Female, pregnant, plan to become pregnant in the next 16-24 months, or currently breastfeeding, 3) Also participating in a clinical trial for an investigational product.      ​​​​​​​


Study Design


Arm Groups

ArmDescriptionIntervention

Trial Ready Cohort

Non-demented adults with Down syndrome (DS)
  • Radiation: MK6240

    All participants at qualifying sites will receive a single bolus intravenous injection of 5 mCi (185 MBq) (± 20%) of MK6240. At approximately 90-minutes post dose, scanning will begin. An approximately 30-minute image acquisition scan will be performed.

    Other names:

    • [18F]MK-6240

  • Radiation: Pittsburgh Compound (PIB)

    All participants at qualifying sites will receive a single bolus intravenous injection of 15 mCi (555 MBq) (± 10%) of PIB. At approximately 30-minutes post dose, scanning will begin. An approximately 30-minute image acquisition scan will be performed.

    Other names:

    • [11C]-PIB
    • PIB

  • Radiation: Flutafuranol

    All participants at qualifying sites will receive a single bolus intravenous injection of 8.1 mCi (300 MBq) (+/- 20%, 10µg mass dose) of flutafuranol ([18F]NAV4694). At approximately 90-minutes post dose, scanning will begin. An approximately 30-minute image acquisition scan will be performed.

    Other names:

    • [18F]NAV4694
    • NAV4694