Phase 2
Completed N=24
Effect of Elderberry Juice on Cognition and Inflammation in Patients With Mild Cognitive Impairment
Source: ClinicalTrials.gov NCT02414607 ↗Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Jun 2022
Primary outcomePrimary: Visuospatial Problem Solving Battery (VSP) — .30; .29; .097; .52 Mean Difference Score (VPS Total Score)
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Visuospatial Problem Solving Battery (VSP) |
.30; .29; .097; .52 | — |
| SECONDARY Clinical Dementia Rating (CDR) Scale |
0; 0; 0; 0 | — |
| SECONDARY Mini-Mental State Examination (MMSE) |
.03; .29; -1.01; .06 | — |
| SECONDARY Hopkins Verbal Learning Test (HVLT) |
-.50; .46; -19; .27 | — |
| SECONDARY Boston Naming Test (BNT) |
1.38; .94; .96; 1.60 | — |
| SECONDARY Rey Complex Figure Task (Rey) |
-1.03; 1.41; -.54; -1.72 | — |
| SECONDARY Anagrams |
-1.81; 2.70; -.41; 1.67 | — |
| SECONDARY Instrumental Activities of Daily Living Scale (IADLS) |
.40; -.34; -30; -44 | — |
Eligibility Criteria
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).
Data sourced from ClinicalTrials.gov (NCT02414607). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.