NCT02414607

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Sep 2016

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 20, 2015

Completed
24 days until next milestone

First Posted

Study publicly available on registry

April 13, 2015

Completed
1.4 years until next milestone

Study Start

First participant enrolled

September 1, 2016

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
2.6 years until next milestone

Results Posted

Study results publicly available

June 23, 2022

Completed
Last Updated

June 23, 2022

Status Verified

May 1, 2022

Enrollment Period

3.2 years

First QC Date

March 20, 2015

Results QC Date

April 28, 2022

Last Update Submit

May 27, 2022

Conditions

Mild Cognitive Impairment

Keywords

Elderberry juiceAlzheimer'sInflammation

Outcome Measures

Primary Outcomes (1)

  • 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.

    12 wks, 6 mos

Secondary Outcomes (7)

  • Clinical Dementia Rating (CDR) Scale

    12 wks, 6 mos

  • Mini-Mental State Examination (MMSE)

    12 wks, 6 mos

  • Hopkins Verbal Learning Test (HVLT)

    12 wks, 6 mos

  • Boston Naming Test (BNT)

    12 wks, 6 mos

  • Rey Complex Figure Task (Rey)

    12 wks, 6 mos

  • +2 more secondary outcomes

Study Arms (2)

Elderberry Juice

EXPERIMENTAL

Participants will drink 5ml of elderberry juice, diluted in 8oz of water, 3 times per day for three months.

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.

Other: Placebo

Interventions

Elderberry JuiceBIOLOGICAL
Elderberry Juice
PlaceboOTHER
Placebo

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Missouri Hospital

Columbia, Missouri, 65212, United States

Location

MeSH Terms

Conditions

Cognitive DysfunctionInflammation

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental DisordersPathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Dr. David Beversdorf
Organization
University of Missouri
beversdorfd@health.missouri.edu
(573) 882-6081

Study Officials

  • David Q Beversdorf, MD

    University of Missouri-Columbia

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor: Radiology, Neurology, Psychology

Study Record Dates

First Submitted

March 20, 2015

First Posted

April 13, 2015

Study Start

September 1, 2016

Primary Completion

December 1, 2019

Study Completion

December 1, 2019

Last Updated

June 23, 2022

Results First Posted

June 23, 2022

Record last verified: 2022-05

Locations

US(1)