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Effect of Elderberry Juice on Cognition and Inflammation in Patients With Mild Cognitive Impairment

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ClinicalTrials.gov Identifier: NCT02414607
Recruitment Status : Recruiting
First Posted : April 13, 2015
Last Update Posted : April 12, 2019
Sponsor:
Information provided by (Responsible Party):
David Beversdorf, University of Missouri-Columbia

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Mild Cognitive Impairment Biological: Elderberry Juice Other: Placebo Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Elderberry Juice on Cognition and Inflammation in Patients With Mild Cognitive Impairment
Study Start Date : September 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : April 2020

Arm Intervention/treatment
Experimental: Elderberry Juice
Participants will drink 5ml of elderberry juice, diluted in 8oz of water, 3 times per day for three months.
Biological: Elderberry Juice
Placebo Comparator: Placebo
Participants will drink 5ml of colored water, diluted in 8oz of water, 3 times per day for three months.
Other: Placebo



Primary Outcome Measures :
  1. Change in Visual Spatial Problem Solving Battery (VSP) [ Time Frame: 12 wks, 6 mos ]
    Problem solving task for detecting non-memory impairments in MCI


Secondary Outcome Measures :
  1. Change in Clinical Dementia Rating (CDR) [ Time Frame: 12 wks, 6 mos ]
    Assesses memory, orientation, judgement and problem solving, community affairs, home/hobbies, personal care.

  2. Change in Mini-Mental State Examination (MMSE) [ Time Frame: 12 wks, 6 mos ]
    Screening for cognitive impairment sampling functions including arithmetic, memory and orientation.

  3. Change in Hopkins Verbal Learning (HVL) [ Time Frame: 12 wks, 6 mos ]
    Assesses verbal learning and memory.

  4. Change in Boston Naming Test (BNT) [ Time Frame: 12 wks, 6 mos ]
    Measures word retrieval

  5. Change in Rey Complex Figure Task (Rey) [ Time Frame: 12 wks, 6 mos ]
    Participants reproduce complicated line drawings.

  6. Change in Anagrams [ Time Frame: 12 wks, 6 mos ]
    Rearranging letters to form words

  7. Change in Instrumental Activities of Daily Living Scale (IADLS) [ Time Frame: 12 wks, 6 mos ]
    Assesses daily self-care activities

  8. Change in Montreal Cognitive Assessment (MoCA) [ Time Frame: 12 wks, 6 mos ]
    Assesses functional performance in: visuospatial/executive, naming, memory, attention, language, abstraction, delayed recall, and orientation



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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • CDR score of 0.5
  • MMSE of at least 24
  • Age 50 or older

Exclusion Criteria:

  • 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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02414607


Contacts
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Contact: David Q Beversdorf, MD 573-882-6081 beversdorfd@health.missouri.edu
Contact: Allison Halt 573-884-4263 akh8c8@mail.missouri.edu

Locations
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United States, Missouri
University of Missouri Hospital Recruiting
Columbia, Missouri, United States, 65212
Contact: David Q Beversdorf, MD    573-882-6081    beversdorfd@health.missouri.edu   
Contact: Allison Halt    573-884-4263    akh8c8@mail.missouri.edu   
Sponsors and Collaborators
University of Missouri-Columbia
Investigators
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Principal Investigator: David Q Beversdorf, MD University of Missouri-Columbia

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Responsible Party: David Beversdorf, Associate Professor: Radiology, Neurology, Psychology, University of Missouri-Columbia
ClinicalTrials.gov Identifier: NCT02414607     History of Changes
Other Study ID Numbers: 1211953
First Posted: April 13, 2015    Key Record Dates
Last Update Posted: April 12, 2019
Last Verified: April 2019
Keywords provided by David Beversdorf, University of Missouri-Columbia:
Elderberry juice
Alzheimer's
Inflammation
Additional relevant MeSH terms:
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Inflammation
Cognitive Dysfunction
Pathologic Processes
Cognition Disorders
Neurocognitive Disorders
Mental Disorders