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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-79
SponsorRousselot BVBA

About this trial

The goal of this clinical trial is 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. The main question it aims to answer is:

What is the effect of AP-Brain at 1 g, 3 g, and 5 g on cognitive performance?

Participants will be asked to consume AP-Brain at 1 g, 3 g, or 5g, or Placebo and asked to complete memory assessment questionnaires.

Eligibility criteria

Qualifiers

Males and females 40-79 years of age, inclusive

Females not of child-bearing potential, defined as those who have undergone a sterilization procedure (e.g. hysterectomy, bilateral oophorectomy, bilateral tubal ligation, complete endometrial ablation) or have been post-menopausal for at least 1 year prior to screening

Hormonal contraceptives including oral contraceptives, hormone birth control patch (Ortho Evra), vaginal contraceptive ring (NuvaRing), injectable contraceptives (Depo-Provera, Lunelle), or hormone implant (Norplant System)

Double-barrier method

Disqualifiers

Individuals who are pregnant, breast feeding, or planning to become pregnant during the study

Allergy, sensitivity, or intolerance to the investigational product or placebo ingredients

Self-reported confirmation of any significant neuropsychological condition and/or cognitive impairment (e.g., attention-deficit/hyperactivity disorder, Schizophrenia, bipolar disorder, post-traumatic stress disorder, brain injury, neurodegenerative disease, infections, insomnia, depression, epileptic or other seizure-related disorders) that could interfere with study participation as assessed by the QI

Self-reported color blindness/weakness as assessed by the QI

Trial design

Treatments tested in this trial

  • AP-Brain (1g)
  • AP-Brain (3g)
  • AP-Brain (5g)
  • Placebo

Treatment groups

120 Participants
are divided into 4 treatment groups

Sponsors and collaborators

Rousselot BVBA

Lead sponsor

KGK Science Inc.

Collaborator