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

• ClinicalTrials.gov Identifier: NCT02502253
• Recruitment Status: Completed
• First Posted: July 20, 2015
• Last Update Posted: July 22, 2022
• Sponsor: Johns Hopkins University
• Collaborator: Icahn School of Medicine at Mount Sinai
• Information provided by (Responsible Party): Johns Hopkins University

Tracking Information

• First Submitted Date: July 8, 2015
• First Posted Date: July 20, 2015
• Last Update Posted Date: July 22, 2022
• Study Start Date: June 2015
• Actual Primary Completion Date: June 1, 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 20, 2022)

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

Original Primary Outcome Measures (submitted: July 17, 2015)

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

• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: BDPP Treatment for Mild Cognitive Impairment (MCI) and Prediabetes or Type 2 Diabetes Mellitus (T2DM)
• Official Title: BDPP Treatment for Mild Cognitive Impairment (MCI) and Prediabetes or Type 2 Diabetes Mellitus (T2DM)

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.

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Prevention

Condition

• Mild Cognitive Impairment
• Alzheimer's Disease

Intervention

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

Study Arms

• Experimental: Low dose
  Intervention: Drug: grape seed polyphenolic extract, resveratrol
• Experimental: moderate dose
  Intervention: Drug: grape seed polyphenolic extract, resveratrol
• Experimental: High dose
  Intervention: Drug: grape seed polyphenolic extract, resveratrol

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: June 9, 2022): 14
• Original Estimated Enrollment (submitted: July 17, 2015): 48
• Actual Study Completion Date: June 1, 2022
• Actual Primary Completion Date: June 1, 2022 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 50 Years to 90 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02502253
• Other Study ID Numbers: IRB00062802
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Johns Hopkins University
• Original Responsible Party: Paul B. Rosenberg, Johns Hopkins University, Associate Professor
• Current Study Sponsor: Johns Hopkins University
• Original Study Sponsor: Same as current
• Collaborators: Icahn School of Medicine at Mount Sinai

Investigators

• Principal Investigator: Paul Roserberg, MD; Johns Hopkins University

• PRS Account: Johns Hopkins University
• Verification Date: June 2022