Mild Cognitive ImpairmentPhase 1BDPPNCT02502253
BDPP Treatment for Mild Cognitive Impairment (MCI) and Prediabetes or Type 2 Diabetes Mellitus (T2DM)
A Phase 1 study testing grape seed polyphenolic extract, resveratrol in people with Mild Cognitive Impairment and Alzheimer's Disease, run by Johns Hopkins University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 to 90 years
- Conditions the study is for
- Mild Cognitive Impairment, Alzheimer's Disease
- What is being tested?
- grape seed polyphenolic extract, resveratrol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2015to 1 Jun 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
- Conditions
- Mild Cognitive Impairment, Alzheimer's Disease
- Being tested
- grape seed polyphenolic extract, resveratrol
- Medical subject headings
- Cognitive Dysfunction, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
grape seed polyphenolic extract, resveratrolDrug
Also called Bioactive Dietary Polyphenol Preparation
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.
| Study group | Role | What they receive |
|---|---|---|
| Low dose | Experimental | Not described Receives: Drug: grape seed polyphenolic extract, resveratrol |
| moderate dose | Experimental | Not described Receives: Drug: grape seed polyphenolic extract, resveratrol |
| High dose | Experimental | Not described Receives: Drug: grape seed polyphenolic extract, resveratrol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Measured: 4 months
Confirm brain penetrance of BDPP by measuring levels of BDPP constituents in cerebrospinal fluid (CSF).
Measured: 4 months
Evaluate BDPP effect on mood with Neuropsychiatric Inventory and Cornell Scale for Depression in Dementia.
Measured: 4 months
Evaluate BDPP effect on cognition with measures of memory, executive function, and attention measures (composite)
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2015 (estimated)
- Study startJun 2015
- Primary completion1 Jun 2022
- Study completion1 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Icahn School of Medicine at Mount Sinai
- Responsible party
- Sponsor
- Investigators
- Paul Roserberg, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02502253
- Sponsor's protocol ID
- IRB00062802
- Acronym
- BDPP
- Status last verified
- Jun 2022
- First submitted
- 8 Jul 2015
- Last updated
- 22 Jul 2022
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BDPP Treatment for Mild Cognitive Impairment (MCI) and Prediabetes or Type 2 Diabetes Mellitus (T2DM)
- ClinicalTrials.gov ID
- NCT02502253
- Acronym / sponsor ID
- BDPP / IRB00062802
- Conditions
- Mild Cognitive Impairment, Alzheimer's Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Icahn School of Medicine at Mount Sinai
- Study start
- Jun 2015
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 1 Jun 2022 (actual)
- First posted
- 20 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low dose | Experimental | Drug: grape seed polyphenolic extract, resveratrol |
| moderate dose | Experimental | Drug: grape seed polyphenolic extract, resveratrol |
| High dose | Experimental | Drug: grape seed polyphenolic extract, resveratrol |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| grape seed polyphenolic extract, resveratrolAlso: Bioactive Dietary Polyphenol PreparationBioactive Dietary Polyphenol Preparation (BDPP) is a combination of two nutraceutical preparations (grape seed polyphenolic extract [GSE], and resveratrol) that contain abundant concentrations of polyphenols. | Drug | High dose, Low dose, moderate dose |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul Roserberg, MD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing grape seed polyphenolic extract, resveratrol in people with Mild Cognitive Impairment and Alzheimer's Disease, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of Adverse Events (AEs) and Serious Adverse Events (SAEs) (time frame: 4 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2022.