BDPP Treatment for Mild Cognitive Impairment (MCI) and Prediabetes or Type 2 Diabetes Mellitus (T2DM)
Condition: Mild Cognitive Impairment; Alzheimer's Disease
MeSH terms: Alzheimer Disease; Diabetes Mellitus; Diabetes Mellitus, Type 2; Prediabetic State; Cognitive Dysfunction
Study type: Interventional
Phase: Phase 1

Summary: 
      Mild Cognitive Impairment (MCI) represents a group of persons who are at risk of incident
      dementia in the near-term. Persons with MCI who have deficits in short-term recall (amnestic
      MCI) are at significant risk of incident Alzheimer's disease (AD) (termed prodromal AD), and
      thus represent a worthy target for secondary prevention interventions.

      There is increasing evidence that risk factors for metabolic syndrome (such as prediabetes
      and type 2 diabetes) increase risk of incident cognitive impairment and possibly AD, and
      evidence that the neurons of the AD brain are in fact insulin resistant with diminished
      glucose uptake under physiological conditions. Thus, persons with MCI and prediabetes or type
      2 diabetes may be at particular risk of incident cognitive impairment and AD.

      A large clinical trial (ACCORD)1 demonstrated that tight control of peripheral blood glucose
      does not improve cognitive (or other health) outcomes in older persons with peripheral
      insulin resistance. Thus, there is a need to target cognitive outcomes in persons with MCI
      and metabolic risk factors, and a drug targeting insulin resistance with good
      blood-brain-barrier (BBB) penetrance can potentially accomplish these objectives. While there
      is a phase III study of intranasal insulin targeting this strategy, nutraceuticals offer a
      low-tech solution that would be more suitable to future secondary prevention trials in MCI.

      Bioactive Dietary Polyphenol Preparation (BDPP) is a combination of two nutraceutical
      preparations grape seed polyphenolic extract (GSE), and resveratrol that contain abundant
      concentrations of polyphenols. The investigators have found that oral BDPP administration was
      associated with improved cognition and brain plasticity long-term potentiation (LTP) in mouse
      models of metabolic syndrome and AD, as well as lowering brain amyloid and tau burden in an
      AD mouse model2-4. The investigators have demonstrated excellent absorption of oral BDPP in a
      small study in humans and similarly excellent CSF penetration of oral BDPP in rats, but it is
      crucial to demonstrate safety and CSF penetration of oral BDPP in humans to assess its
      potential as a treatment for MCI and prediabetes or type 2 diabetes.
    


Intervention name(s): grape seed polyphenolic extract, resveratrol
Intervention type(s): Drug
Intervention description(s): Bioactive Dietary Polyphenol Preparation (BDPP) is a combination of two nutraceutical preparations (grape seed polyphenolic extract [GSE], and resveratrol) that contain abundant concentrations of polyphenols.
Other intervention name(s): Bioactive Dietary Polyphenol Preparation
Intervention MeSH terms: Resveratrol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention