Mild Cognitive ImpairmentPhase 1/2NCT02414607
Effect of Elderberry Juice on Cognition and Inflammation in Patients With Mild Cognitive Impairment
A Phase 1/2 study testing Elderberry Juice in people with Mild Cognitive Impairment, run by University of Missouri-Columbia at 1 site in United States.
Trial summary
Elderberries (Sambuci fructus) have been shown in a number of studies to have significant anti-inflammatory and antioxidant effects. Multiple human and animal studies have supported the anti-inflammatory and antioxidant effects of elderberry preparations and it has been used in natural medicine for hundreds of years. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Mild Cognitive Impairment
- What is being tested?
- Elderberry Juice
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2016to Dec 2019
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- CDR score of 0.5
- MMSE of at least 24
- Age 50 or older
Who cannot join
- Known history of sensitivity to elderberry products.
- Diabetes.
- Bleeding disorder.
- Current Pregnancy.
- Known allergy to honeysuckle.
- Currently making changes to other drugs that might affect cognitive performance (subjects showing the greatest cognitive decline and other signs of Alzheimer's disease may be prescribed cholinesterase inhibitors as this is a standard of care for Alzheimer's disease but not MCI).
- Presence of any condition the health professional believes will impair ability to complete study procedures (ex. terminal illness, comorbid major psychiatric disorders such as schizophrenia, or drug abuse).
- Potentially confounding neurodegenerative diseases (e.g. MS).
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Missouri Hospital
Columbia, Missouri, 65212
About this study
Elderberries (Sambuci fructus) have been shown in a number of studies to have significant anti-inflammatory and antioxidant effects. Multiple human and animal studies have supported the anti-inflammatory and antioxidant effects of elderberry preparations and it has been used in natural medicine for hundreds of years. Studies examining factors that may decrease the risk of Alzheimer's disease have revealed that drinking juices with similar properties to elderberries is one of the most reliable way to decrease risk. As such the investigators wish to determine the effects of elderberry juice on cognitive decline in a group of subjects at high risk for Alzheimer's disease, those with mild cognitive impairment. Elderberry juice is a commercially available nutritional supplement and easily available to this population.
- Conditions
- Mild Cognitive Impairment
- Being tested
- Elderberry Juice, Placebo
- Keywords
- Elderberry juice, Alzheimer's, Inflammation
- Medical subject headings
- Cognitive Dysfunction, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Elderberry JuiceBiological
PlaceboOther
| Study group | Role | What they receive |
|---|---|---|
| Elderberry Juice | Experimental | Participants will drink 5ml of elderberry juice, diluted in 8oz of water, 3 times per day for three months. Receives: Biological: Elderberry Juice |
| Placebo | Placebo comparator | Participants will drink 5ml of colored water, diluted in 8oz of water, 3 times per day for three months. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visuospatial Problem Solving Battery (VSP)
Problem solving task for detecting non-memory impairments in MCI. Change in score is the outcome measure. The task is a timed task, with the outcome measured in seconds. Each item was allowed 240 seconds for solution, with times averaged for items. Therefore, there was a range of 0-240 with lower being better.
Measured: 12 wks, 6 mos
Secondary outcomes (7)
Clinical Dementia Rating (CDR) Scale
Assesses memory, orientation, judgement and problem solving, community affairs, home/hobbies, personal care. Change in CDR was the outcome. CDR ranges from 0 to 3, with 3 being worse.
Measured: 12 wks, 6 mos
Mini-Mental State Examination (MMSE)
Screening for cognitive impairment sampling functions including arithmetic, memory and orientation. Change in MMSE was the outcome. the MMSE is a scale from 0 to 30 with a higher score being better.
Measured: 12 wks, 6 mos
Hopkins Verbal Learning Test (HVLT)
Assesses verbal learning and memory. Change in the HVLT was the outcome measure. The range for the HVLT is 0-36 with higher representing better memory.
Measured: 12 wks, 6 mos
Boston Naming Test (BNT)
Measures word retrieval. Change in the BNT is the primary outcome measure. The range is 0-60 with higher representing better performance.
Measured: 12 wks, 6 mos
Rey Complex Figure Task (Rey)
Participants reproduce complicated line drawings. Change in the Rey was the primary outcome measure. The range of the Rey is 0-36 with a higher score being better performance.
Measured: 12 wks, 6 mos
Anagrams
Rearranging letters to form words. Change in performance is the primary outcome measure. The task is timed, with each anagram allowed 120 seconds, so each word has a range of 0-120 seconds, and the average for the latency was calculated, for a range of 0-120 with lower numbers being better.
Measured: 12 wks, 6 mos
Instrumental Activities of Daily Living Scale (IADLS)
Assesses daily self-care activities. Change in the IADLS is the primary outcome. Total items were added together for this use of the task, so the range was from 0 to 23, with higher being better.
Measured: 12 wks, 6 mos
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2015 (estimated)
- Study startSep 2016
- Primary completionDec 2019
- Study completionDec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- More trials run by University of Missouri-ColumbiaThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Missouri-Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Beversdorf, University of Missouri-Columbia
- Investigators
- David Q Beversdorf, MD, Principal investigator, University of Missouri-Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02414607
- Sponsor's protocol ID
- 1211953
- Status last verified
- May 2022
- First submitted
- 20 Mar 2015
- Last updated
- 23 Jun 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Elderberry Juice on Cognition and Inflammation in Patients With Mild Cognitive Impairment
- ClinicalTrials.gov ID
- NCT02414607
- Acronym / sponsor ID
- 1211953
- Conditions
- Mild Cognitive Impairment
- Keywords
- Elderberry juice, Alzheimer's, Inflammation
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of Missouri-ColumbiaUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- Dec 2019 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 13 Apr 2015 (estimated)
- Results
- Posted 23 Jun 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Elderberries (Sambuci fructus) have been shown in a number of studies to have significant anti-inflammatory and antioxidant effects. Multiple human and animal studies have supported the anti-inflammatory and antioxidant effects of elderberry preparations and it has been used in natural medicine for hundreds of years. Studies examining factors that may decrease the risk of Alzheimer's disease have revealed that drinking juices with similar properties to elderberries is one of the most reliable way to decrease risk. As such the investigators wish to determine the effects of elderberry juice on cognitive decline in a group of subjects at high risk for Alzheimer's disease, those with mild cognitive impairment. Elderberry juice is a commercially available nutritional supplement and easily available to this population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Elderberry Juice | Experimental | Biological: Elderberry JuiceParticipants will drink 5ml of elderberry juice, diluted in 8oz of water, 3 times per day for three months. |
| Placebo | Placebo comparator | Other: PlaceboParticipants will drink 5ml of colored water, diluted in 8oz of water, 3 times per day for three months. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- CDR score of 0.5
- MMSE of at least 24
- Age 50 or older
Key exclusion criteria (8 listed)
- Known history of sensitivity to elderberry products.
- Diabetes.
- Bleeding disorder.
- Current Pregnancy.
- Known allergy to honeysuckle.
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 |
|---|---|---|
| Elderberry Juice | Biological | Elderberry Juice |
| Placebo | Other | Placebo |
Primary outcome
Visuospatial Problem Solving Battery (VSP)
Time frame: 12 wks, 6 mos
Problem solving task for detecting non-memory impairments in MCI. Change in score is the outcome measure. The task is a timed task, with the outcome measured in seconds. Each item was allowed 240 seconds for solution, with times averaged for items. Therefore, there was a range of 0-240 with lower being better.
7 secondary outcomes
Clinical Dementia Rating (CDR) Scale
Time frame: 12 wks, 6 mos
Mini-Mental State Examination (MMSE)
Time frame: 12 wks, 6 mos
Hopkins Verbal Learning Test (HVLT)
Time frame: 12 wks, 6 mos
Boston Naming Test (BNT)
Time frame: 12 wks, 6 mos
Rey Complex Figure Task (Rey)
Time frame: 12 wks, 6 mos
Anagrams
Time frame: 12 wks, 6 mos
Instrumental Activities of Daily Living Scale (IADLS)
Time frame: 12 wks, 6 mos
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Mild Cognitive Impairment
RecruitingPhase 1
PET Imaging of Phosphodiesterase-4 (PDE4) in Volunteers With Alzheimer Disease (AD) or Mild Cognitive Impairment (MCI)
Alzheimer s Disease, Mild Cognitive Impairment
RecruitingObservational study
Community-based Screening for Alzheimer's Disease
Alzheimer's Disease(AD), Mild Cognitive Impairment (MCI)
RecruitingObservational study
InRAD Observational Study
Alzheimer's Disease(AD), Mild Cognitive Impairment (MCI)
Recruiting
Treating Insomnia in Mild Cognitive Impairment
Mild Cognitive Impairment (MCI), Insomnia
Recruiting
Telehealth-Adapted Compensatory Training and Intervention for Cognition
MCI, Mild Cognitive Impairment
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.
David Q Beversdorf, MD principal investigator
University of Missouri-Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Elderberry Juice in people with Mild Cognitive Impairment, run by University of Missouri-Columbia 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 3 inclusion and 8 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 23 Jun 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. 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.
What does this combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Jun 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Visuospatial Problem Solving Battery (VSP) (time frame: 12 wks, 6 mos). 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 23 Jun 2022.