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
|Condition or disease||Intervention/treatment||Phase|
|Mild Cognitive Impairment||Biological: Elderberry Juice Other: Placebo||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
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.
- Change in Visual Spatial Problem Solving Battery (VSP) [ Time Frame: 12 wks, 6 mos ]Problem solving task for detecting non-memory impairments in MCI
- 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.
- Change in Mini-Mental State Examination (MMSE) [ Time Frame: 12 wks, 6 mos ]Screening for cognitive impairment sampling functions including arithmetic, memory and orientation.
- Change in Hopkins Verbal Learning (HVL) [ Time Frame: 12 wks, 6 mos ]Assesses verbal learning and memory.
- Change in Boston Naming Test (BNT) [ Time Frame: 12 wks, 6 mos ]Measures word retrieval
- Change in Rey Complex Figure Task (Rey) [ Time Frame: 12 wks, 6 mos ]Participants reproduce complicated line drawings.
- Change in Anagrams [ Time Frame: 12 wks, 6 mos ]Rearranging letters to form words
- Change in Instrumental Activities of Daily Living Scale (IADLS) [ Time Frame: 12 wks, 6 mos ]Assesses daily self-care activities
- 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
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
|Contact: David Q Beversdorf, MDemail@example.com|
|Contact: Allison Haltfirstname.lastname@example.org|
|United States, Missouri|
|University of Missouri Hospital||Recruiting|
|Columbia, Missouri, United States, 65212|
|Contact: David Q Beversdorf, MD 573-882-6081 email@example.com|
|Contact: Allison Halt 573-884-4263 firstname.lastname@example.org|
|Principal Investigator:||David Q Beversdorf, MD||University of Missouri-Columbia|