BDPP Treatment for Mild Cognitive Impairment (MCI) and Prediabetes or Type 2 Diabetes Mellitus (T2DM)
| Status: | Recruiting |
|---|---|
| Conditions: | Alzheimer Disease, Cognitive Studies, Endocrine, Diabetes, Diabetes, Diabetes |
| Therapuetic Areas: | Endocrinology, Neurology, Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 50 - 90 |
| Updated: | 6/28/2018 |
| Start Date: | June 2015 |
| End Date: | October 2019 |
| Contact: | Sarah Lawrence, MS |
| Email: | swoody1@jhmi.edu |
| Phone: | 410-550-9020 |
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.
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.
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
We found this trial at
1
site
3400 N Charles St
Baltimore, Maryland 21205
Baltimore, Maryland 21205
410-516-8000
Phone: 410-550-9020
Johns Hopkins University The Johns Hopkins University opened in 1876, with the inauguration of its...
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