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Completed

NCT Number: NCT02414607

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

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.

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Key information

Conditions

Mild Cognitive Impairment Cognition Disorders Cognitive Dysfunction Inflammation Mental Disorders Neurocognitive Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

University of Missouri Hospital

Columbia, Missouri, 65212, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Elderberry Juice

Biological

Placebo

Other

Primary outcomes

  1. 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.

Secondary outcomes

  1. Clinical Dementia Rating (CDR) Scale

    Time frame: 12 wks, 6 mos

    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.

  2. Mini-Mental State Examination (MMSE)

    Time frame: 12 wks, 6 mos

    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.

  3. Hopkins Verbal Learning Test (HVLT)

    Time frame: 12 wks, 6 mos

    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.

  4. Boston Naming Test (BNT)

    Time frame: 12 wks, 6 mos

    Measures word retrieval. Change in the BNT is the primary outcome measure. The range is 0-60 with higher representing better performance.

  5. Rey Complex Figure Task (Rey)

    Time frame: 12 wks, 6 mos

    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.

  6. Anagrams

    Time frame: 12 wks, 6 mos

    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.

  7. Instrumental Activities of Daily Living Scale (IADLS)

    Time frame: 12 wks, 6 mos

    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.

Sponsors and collaborators

Lead sponsor

University of Missouri-Columbia

Other

Registry information

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Apr 13, 2015
Registry last updated
Jun 23, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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