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NCT02502253: BDPP

BDPP Treatment for Mild Cognitive Impairment (MCI) and Prediabetes or Type 2 Diabetes Mellitus (T2DM)

Completed Phase 1 Last updated 20 July 2022
What this trial tests

Phase 1 trial testing grape seed polyphenolic extract, resveratrol in Mild Cognitive Impairment in 14 participants. Completed in 1 June 2022.

Timeline
1 June 2015
Primary endpoint
1 June 2022
1 June 2022

Quick facts

Lead sponsorJohns Hopkins University
PhasePhase 1
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingquadruple
Primary purposeprevention
Enrollment14
Start date1 June 2015
Primary completion1 June 2022
Estimated completion1 June 2022
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Johns Hopkins University

Who can join

Adults 50 to 90, any sex, with Mild Cognitive Impairment or Alzheimer's Disease. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Slowing ageing by design: the rise of NAD<sup>+</sup> and sirtuin-activating compounds.
    Bonkowski MS, Sinclair DA. · · 2016 · cited 639× · PMID 27552971 · DOI 10.1038/nrm.2016.93
  2. Alzheimer's disease drug development pipeline: 2019.
    Cummings J, Lee G, Ritter A, Sabbagh M, et al · · 2019 · cited 485× · PMID 31334330 · DOI 10.1016/j.trci.2019.05.008
  3. Alzheimer's disease drug development pipeline: 2022.
    Cummings J, Lee G, Nahed P, Kambar MEZN, et al · · 2022 · cited 369× · PMID 35516416 · DOI 10.1002/trc2.12295
  4. Alzheimer's disease drug development pipeline: 2020.
    Cummings J, Lee G, Ritter A, Sabbagh M, et al · · 2020 · cited 350× · PMID 32695874 · DOI 10.1002/trc2.12050
  5. Alzheimer's disease drug development pipeline: 2021.
    Cummings J, Lee G, Zhong K, Fonseca J, et al · · 2021 · cited 312× · PMID 34095440 · DOI 10.1002/trc2.12179
  6. Pathological mechanisms and therapeutic strategies for Alzheimer's disease.
    Ju Y, Tam KY. · · 2022 · cited 260× · PMID 34380884 · DOI 10.4103/1673-5374.320970
  7. Mitochondria as a therapeutic target for cardiac ischemia‑reperfusion injury (Review).
    Marin W, Marin D, Ao X, Liu Y. · · 2021 · cited 101× · PMID 33416090 · DOI 10.3892/ijmm.2020.4823
  8. Mitochondrial complex I as a therapeutic target for Alzheimer's disease.
    Trushina E, Trushin S, Hasan MF. · · 2022 · cited 94× · PMID 35256930 · DOI 10.1016/j.apsb.2021.11.003

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