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


Last Updated: 12-12-2014
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