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

Study Overview
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Brief Summary
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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.

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

Conditions
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Mild Cognitive Impairment

Intervention / Treatment
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* Biological: Elderberry Juice
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Elderberry Juice<br>Participants will drink 5ml of elderberry juice, diluted in 8oz of water, 3 times per day for three months. | Biological: Elderberry Juice<br> <br> |
| Placebo Comparator: Placebo<br>Participants will drink 5ml of colored water, diluted in 8oz of water, 3 times per day for three months. | Other: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 12 wks, 6 mos | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Elderberry juice, Alzheimer's, Inflammation