Mild Cognitive ImpairmentNCT02741804
Lifestyle Intervention Program for Cognitive Impairment
A study testing BBH-1001 Brain Health Supplement and Lifestyle Intervention in people with Mild Cognitive Impairment, run by Cedars-Sinai Medical Center at 1 site in United States.
Trial summary
The purpose of the Lifestyle Intervention Study is to investigate the influence of a micronutrient supplement in combination with a comprehensive lifestyle intervention program on retinal amyloid, among patients with Mild Cognitive Impairment (MCI). Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Mild Cognitive Impairment
- What is being tested?
- BBH-1001 Brain Health Supplement and Lifestyle Intervention
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- May 2016to May 2019
- Phase
- Interventional
- 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 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 55 years of age
- Experiencing memory, or cognitive problems
Who cannot join
- Patients < 55 years of age
- Previously diagnosed dementia; suspected dementia after clinical assessment by study physician at screening visit
- Mini Mental State Examination (MMSE) score less than 20 points
- Disorders affecting safe engagement in the intervention (e.g., malignant disease, major depression, psychiatric disease, symptomatic cardiovascular disease, revascularization within 1 year previously)
- Unable to safely change diet
- Patients without the means to visit the clinic on the assigned dates
Show all 13Show fewer
- Patients that cannot comply with the data gathering needs of the study
- Severe loss of vision, hearing, or communicative ability
- Disorders preventing cooperation as judged by the study physician
- Coincident participation in another intervention trial
- Allergy to any ingredient in the supplement or placebo (i.e. soybean oil)
- Patients with gallstones due to possible interactions with turmeric
- Participants who are unable to provide clearance from their physician to participate in the physical activity training, as well as confirmed by Dr. Sherzai during the neurological exam.
Trial locations and contacts
1 site in 1 country.
United States1 site
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Wendy Weissberg, 310-423-5357, weissbergg@cshs.org
Georgia Rochester, 3104236587, georgia.rochester@cshs.org
About this study
Official title: A Multi-domain Lifestyle Intervention Protocol to Detect Changes in Retinal Amyloid Among Individuals With Mild Cognitive Impairment
The purpose of the Lifestyle Intervention Study is to investigate the influence of a micronutrient supplement in combination with a comprehensive lifestyle intervention program on retinal amyloid, among patients with Mild Cognitive Impairment (MCI). Patients will be placed on supplement or placebo throughout their 18-month study participation. Patients will also be given lifestyle training on nutrition, physical activity, cognitive and social activity, meditation and sleep, which have all been proven to positively affect cognition over time. Throughout their participation, patients' cognitive functioning will be monitored with comprehensive imaging, neuropsychological testing, blood testing and study compliance.
- Conditions
- Mild Cognitive Impairment
- Being tested
- BBH-1001 Brain Health Supplement, Lifestyle Intervention, Brain Health Placebo
- Keywords
- Memory
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BBH-1001 Brain Health SupplementDietary supplement
Treatment with supplement consisting of turmeric, fish oil, vitamin D and green tea extract OR placebo.
Lifestyle InterventionOther
All patients will be given lessons on 6 areas of lifestyle: nutrition, physical activity, meditation, sleep hygiene, cognitive activity, and social activity.
Brain Health PlaceboDietary supplement
Treatment with placebo consisting of soybean oil
| Study group | Role | What they receive |
|---|---|---|
| BBH-1001 Brain Health Supplement | Active comparator | Patients will be given supplement containing ingredients all approved by the FDA: Turmeric (125mg), fisetin (16.65mg), green tea leaf extract (17.5mg), EPA (75mg), DHA (150mg) and Vitamin D3 (250IU). Patients will take 4 softgels once per day for entire study duration (18 months). Receives: Dietary Supplement: BBH-1001 Brain Health Supplement; Other: Lifestyle Intervention |
| Brain Health Placebo | Placebo comparator | Patients will be given a pill resembling the study supplement, but instead consisting of Soybean oil (608mg). Patients will take 4 softgels once per day for the entire study duration (18 months). Receives: Other: Lifestyle Intervention; Dietary Supplement: Brain Health Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in retinal amyloid burden, as measured by retinal amyloid scan.
Patients will be given a retinal scan at baseline, 6 months, 12 months and end of study (18 months). The retinal scanner is an device that measures the buildup of amyloid proteins in the brain via imaging of the eye. The change in amyloid buildup between each time point will be measured to determine effect of the interventions.
Measured: baseline and 18 months
Secondary outcomes (5)
Change in Neuropsychology
- Cognitive performance measured by Neuropsychological Test Battery, evaluating several cognitive domains, which are sensitive measures for mild cognitive changes
Measured: baseline and 18 months
Diagnosis of Dementia
- Incidence dementia and Alzheimer's disease (according to standard criteria, NINCDS-ADRDA). An extended follow-up of at least 7-10 years is needed to investigate the effect of the intervention on this outcome.
Measured: baseline and 7-10 years
Change in Neuroimaging
- Neuroimaging via data review (structural and functional brain MRI and FDG-PET).
Measured: baseline and 18 months
Change in Lab Results
- Serum and plasma lab tests (inflammatory, metabolic, lipid and glucose metabolism, serum vitamin levels)
Measured: baseline and 18 months
Change in Vascular Risk Factors
- Vascular risk factor markers (blood pressure, blood glucose and HgA1c, lipid panel)
Measured: baseline and 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2016 (estimated)
- Study startMay 2016
- Primary completionMay 2019 (estimated)
- Study completionMay 2019 (estimated)
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.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayesha Sherzai, MD, Cedars-Sinai Medical Center
- Investigators
- Ayesha Sherzai, MD, Principal investigator, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02741804
- Sponsor's protocol ID
- 41387
- Status last verified
- Jun 2016
- First submitted
- 7 Apr 2016
- Last updated
- 27 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-domain Lifestyle Intervention Protocol to Detect Changes in Retinal Amyloid Among Individuals With Mild Cognitive Impairment
- ClinicalTrials.gov ID
- NCT02741804
- Acronym / sponsor ID
- 41387
- Conditions
- Mild Cognitive Impairment
- Keywords
- Memory
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- May 2019 (estimated)
- Study completion
- May 2019 (estimated)
- First posted
- 18 Apr 2016 (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.
The purpose of the Lifestyle Intervention Study is to investigate the influence of a micronutrient supplement in combination with a comprehensive lifestyle intervention program on retinal amyloid, among patients with Mild Cognitive Impairment (MCI). Patients will be placed on supplement or placebo throughout their 18-month study participation. Patients will also be given lifestyle training on nutrition, physical activity, cognitive and social activity, meditation and sleep, which have all been proven to positively affect cognition over time. Throughout their participation, patients' cognitive functioning will be monitored with comprehensive imaging, neuropsychological testing, blood testing and study compliance.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BBH-1001 Brain Health Supplement | Active comparator | Dietary Supplement: BBH-1001 Brain Health Supplement, Other: Lifestyle InterventionPatients will be given supplement containing ingredients all approved by the FDA: Turmeric (125mg), fisetin (16.65mg), green tea leaf extract (17.5mg), EPA (75mg), DHA (150mg) and Vitamin D3 (250IU). Patients will take 4 softgels once per day for entire study duration (18 months). |
| Brain Health Placebo | Placebo comparator | Other: Lifestyle Intervention, Dietary Supplement: Brain Health PlaceboPatients will be given a pill resembling the study supplement, but instead consisting of Soybean oil (608mg). Patients will take 4 softgels once per day for the entire study duration (18 months). |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age ≥ 55 years of age
- Experiencing memory, or cognitive problems
Key exclusion criteria (13 listed)
- Patients < 55 years of age
- Previously diagnosed dementia; suspected dementia after clinical assessment by study physician at screening visit
- Mini Mental State Examination (MMSE) score less than 20 points
- Disorders affecting safe engagement in the intervention (e.g., malignant disease, major depression, psychiatric disease, symptomatic cardiovascular disease, revascularization within 1 year previously)
- Unable to safely change diet
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 |
|---|---|---|
| BBH-1001 Brain Health SupplementTreatment with supplement consisting of turmeric, fish oil, vitamin D and green tea extract OR placebo. | Dietary supplement | BBH-1001 Brain Health Supplement |
| Lifestyle InterventionAll patients will be given lessons on 6 areas of lifestyle: nutrition, physical activity, meditation, sleep hygiene, cognitive activity, and social activity. | Other | BBH-1001 Brain Health Supplement, Brain Health Placebo |
| Brain Health PlaceboTreatment with placebo consisting of soybean oil | Dietary supplement | Brain Health Placebo |
Primary outcome
Change in retinal amyloid burden, as measured by retinal amyloid scan.
Time frame: baseline and 18 months
Patients will be given a retinal scan at baseline, 6 months, 12 months and end of study (18 months). The retinal scanner is an device that measures the buildup of amyloid proteins in the brain via imaging of the eye. The change in amyloid buildup between each time point will be measured to determine effect of the interventions.
5 secondary outcomes
Change in Neuropsychology
Time frame: baseline and 18 months
Diagnosis of Dementia
Time frame: baseline and 7-10 years
Change in Neuroimaging
Time frame: baseline and 18 months
Change in Lab Results
Time frame: baseline and 18 months
Change in Vascular Risk Factors
Time frame: baseline and 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2016.
- Individual participant dataSharing planned: No
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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.
Ayesha Sherzai, MD principal investigator
Cedars-Sinai Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BBH-1001 Brain Health Supplement and Lifestyle Intervention in people with Mild Cognitive Impairment, run by Cedars-Sinai Medical Center 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 2 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 27 Jun 2016. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wendy Weissberg, BS (3104235357, weissbergg@cshs.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in retinal amyloid burden, as measured by retinal amyloid scan. (time frame: baseline and 18 months). 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 27 Jun 2016.