S-Connect
Short Study Name (acronym):S-Connect
Long Name:A Randomized Controlled Trial to Assess the Efficacy of a Medical Food in Patients with Mild to Moderate Alzheimer’s Disease using Alzheimer’s Disease Medication
Investigators (list PI first):
Kaycee Sink, MD
Jeff Williamson, MD
Funding Agency:
Danone Research
Funding Dates:
11/2009 – 11/2010
Research questions or aims:
To assess the effect on, functional abilities, cognition, global clinical impression, blood chemistry, tolerance and safety during 24 weeks’ intake of investigational product, Souvenaid® containing FortasynTM Connect compared to a control product. Souvenaid is a specific combination of nutrients, and is intended to be used as a food compared to control product in patients with mild to moderate AD.
Target population:
Male and female age ≥ 50 years who have a diagnosis of probable Alzheimer’s disease, use an approved AD medication and have a reliable study partner.
Target # to enroll:
Up to 20
Target Dates of enrollment:
March 2009 – July 2010
Types of assessments and questionnaires:
Medical History, Demographics, height, weight, Vital Signs, calfcircumference, Concomitant Medications, cognitive test battery, MMSE, CDR–SB (Clinical Dementia Rating Sum of Boxes), ADAS-COG(Alzheimer's Disease Assessment Scale-cognitive subscale), ADCS-ADL, EQ-5D (European Quality of Life-5 Dimensions), RUD Lite (Resource Utilization in Dementia Lite)
Other data collected:
Blood sample for safety, efficacy and biomarkers
Coordinator Contact Info:
Sheri Mayer
Email: smayer@wakehealth.edu
Phone: 336-713-8520