S-Connect

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

 

The primary objective of this study is to assess the effect on cognition during 24 weeks’ intake of investigational product compared to control product in patients with mild to moderate AD. The secondary objective of this study is to assess the effect on functional abilities, cognition, global clinical impression, blood chemistry, tolerance and safety during 24 weeks’ intake of investigational product compared to control product in patients with mild to moderate AD. Patients with AD who appear to fulfil the eligibility criteria are informed about the study and invited for a screening visit. Patients meeting the in- and exclusion criteria are enrolled directly (combined screening-baseline visit) or during a separate baseline visit. The patients are randomly allocated to either the investigational or control arm for a double-blind period of 24 weeks. At baseline, 12, and 24 weeks the major study parameters are assessed. To keep the patients motivated, to optimise study product compliance, and to dispense study product, additional visits are conducted at 6 and 18 weeks. For motivation and compliance, phone calls are conducted at 3, 9, 15, and 21 weeks. A final follow-up call is done 2 weeks after the last site visit. This is a 24-weeks, randomized, controlled, double-blind, parallel-group, multicentre trial.

Last Updated: 08-21-2015
USNWR 2015-2016Magnet Hospital RecognitionConsumer Choice2014 Best DoctorsJoint Commission Report

Disclaimer: The information on this website is for general informational purposes only and SHOULD NOT be relied upon as a substitute for sound professional medical advice, evaluation or care from your physician or other qualified health care provider.