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

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ClinicalTrials.gov Identifier: NCT02502253
Recruitment Status : Recruiting
First Posted : July 20, 2015
Last Update Posted : October 27, 2017
Sponsor:
Collaborator:
Icahn School of Medicine at Mount Sinai
Information provided by (Responsible Party):
Johns Hopkins University

Brief 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.


Condition or disease Intervention/treatment Phase
Mild Cognitive Impairment Alzheimer's Disease Drug: grape seed polyphenolic extract, resveratrol Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: BDPP Treatment for Mild Cognitive Impairment (MCI) and Prediabetes or Type 2 Diabetes Mellitus (T2DM)
Study Start Date : June 2015
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : October 2018


Arm Intervention/treatment
Experimental: Low dose Drug: grape seed polyphenolic extract, resveratrol
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 Name: Bioactive Dietary Polyphenol Preparation

Experimental: moderate dose Drug: grape seed polyphenolic extract, resveratrol
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 Name: Bioactive Dietary Polyphenol Preparation

Experimental: High dose Drug: grape seed polyphenolic extract, resveratrol
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 Name: Bioactive Dietary Polyphenol Preparation




Primary Outcome Measures :
  1. Assessment of Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: 4 months ]
  2. Confirm brain penetrance of BDPP by measuring levels of BDPP constituents in cerebrospinal fluid (CSF). [ Time Frame: 4 months ]
  3. Evaluate BDPP effect on mood with Neuropsychiatric Inventory and Cornell Scale for Depression in Dementia. [ Time Frame: 4 months ]
  4. Evaluate BDPP effect on cognition with a composite battery of memory, executive function, and attention measures (composite) [ Time Frame: 4 months ]


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Ages Eligible for Study:   50 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 50-90 years inclusive
  • Amnestic MCI
  • Impaired fasting glucose (IFG), defined by American Diabetes Association criteria (fasting blood sugar between 100 and 125 mg/dl) or clinically stable type 2 diabetes
  • Knowledgeable informant (KI) who spends at least 5 hours/week with the participant and can provide information about the participant's psychosocial functioning

Exclusion Criteria:

  • Deemed too unstable medically or neurologically to safely enroll in trial of research medication
  • Type 1 Diabetes Mellitus
  • Diagnosis of dementia due to Alzheimer's disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02502253


Contacts
Contact: Sarah Lawrence, MS 410-550-9020 swoody1@jhmi.edu
Contact: Toni White, BA 410-550-6486 twhite46@jhmi.edu

Locations
United States, Maryland
Johns Hopkins University Recruiting
Baltimore, Maryland, United States, 21224
Contact: Sarah Lawrence, MS    410-550-9020      
Contact: Meghan Schultz, MSN    410-550-4258      
Sponsors and Collaborators
Johns Hopkins University
Icahn School of Medicine at Mount Sinai

Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT02502253     History of Changes
Other Study ID Numbers: IRB00062802
First Posted: July 20, 2015    Key Record Dates
Last Update Posted: October 27, 2017
Last Verified: October 2017

Additional relevant MeSH terms:
Resveratrol
Diabetes Mellitus
Alzheimer Disease
Diabetes Mellitus, Type 2
Cognitive Dysfunction
Prediabetic State
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Cognition Disorders
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Antioxidants
Molecular Mechanisms of Pharmacological Action