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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Elderberry Juice | Experimental | Participants will drink 5ml of elderberry juice, diluted in 8oz of water, 3 times per day for three months. |
|
| Placebo | Placebo Comparator | Participants will drink 5ml of colored water, diluted in 8oz of water, 3 times per day for three months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Elderberry Juice | Biological |
| ||
| Placebo |
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Q Beversdorf, MD | University of Missouri-Columbia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Missouri Hospital | Columbia | Missouri | 65212 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Elderberry Juice | Participants will drink 5ml of elderberry juice, diluted in 8oz of water, 3 times per day for three months. Elderberry Juice |
| FG001 | Placebo | Participants will drink 5ml of colored water, diluted in 8oz of water, 3 times per day for three months. Placebo |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Elderberry Juice | Participants will drink 5ml of elderberry juice, diluted in 8oz of water, 3 times per day for three months. Elderberry Juice |
| BG001 | Placebo | Participants will drink 5ml of colored water, diluted in 8oz of water, 3 times per day for three months. Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Error | Mean Difference Score (VPS Total Score) | 12 wks, 6 mos |
|
6 months
Serious adverse events or adverse events were documented.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Elderberry Juice | Participants will drink 5ml of elderberry juice, diluted in 8oz of water, 3 times per day for three months. Elderberry Juice |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Non-serious adverse event | Skin and subcutaneous tissue disorders | Systematic Assessment | Acute skin rash |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. David Beversdorf | University of Missouri | (573) 882-6081 | beversdorfd@health.missouri.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 11, 2016 | Apr 28, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 28, 2020 | Apr 28, 2022 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D010335 | Pathologic Processes |
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|
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 |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Error | Mean difference on CDR scale | 12 wks, 6 mos |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Error | Mean Difference Score (MMSE) | 12 wks, 6 mos |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Error | Mean Difference Score (HVL Free Recall) | 12 wks, 6 mos |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Error | Mean Difference Score (BNT Total) | 12 wks, 6 mos |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Error | Mean Difference Score (REY Copy Score) | 12 wks, 6 mos |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Error | Mean Difference Score (Anagrams Total) | 12 wks, 6 mos |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Error | Mean Difference Score (IADL) | 12 wks, 6 mos |
|
|
|
| 0 |
| 11 |
| 0 |
| 11 |
| 0 |
| 11 |
| EG001 | Placebo | Participants will drink 5ml of colored water, diluted in 8oz of water, 3 times per day for three months. Placebo | 0 | 13 | 0 | 13 | 1 | 13 |
|
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| D013568 |
| Pathological Conditions, Signs and Symptoms |