Study of AP-Brain Dietary Supplement Effects on Memory and Thinking in Healthy Adults Aged 40 to 79 with Memory Concerns

What this Trial Is About

Researchers are evaluating the safety and effects of AP-Brain, a dietary supplement containing hydrolyzed collagen, on cognitive performance in healthy middle-aged and older adults who have reported memory problems. The study aims to understand how different doses of AP-Brain 1 g, 3 g, and 5 g compare to a placebo in impacting cognitive abilities. This trial is designed as a randomized, triple-blind, placebo-controlled proof of concept study. Participants will be assigned to one of four groups receiving either 1 g, 3 g, or 5 g of AP-Brain, or a placebo. Each dose consists of five capsules taken with a standardized meal during an in-clinic visit, with the number of AP-Brain capsules and placebo capsules varying per group to maintain blinding. The study duration is 56 days, during which cognitive performance will be assessed at various time points. Throughout the study, participants will complete memory assessment questionnaires and undergo neurocognitive testing using the CNS Vital Signs CNS VS test battery. Researchers will measure changes in cognitive performance, including attention, memory, processing speed, executive function, and other brain functions. Safety is monitored through medical history, lab tests, and vital signs. The main outcome is the change in cognitive scores from baseline to Day 56, with secondary outcomes assessing earlier changes and biological markers. Participants are expected to maintain lifestyle habits and adhere to restrictions on caffeine, alcohol, medications, and exercise around visits.

A Clinical Trial to Investigate the Safety and Efficacy of AP-Brain on Cognitive Performance at Varying Dosages in Healthy Middle-aged and Older Adults With Self-reported Memory Problems