Mild Cognitive Impairment
Conditions
Keywords
Elderberry juice, Alzheimer's, Inflammation
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.
Interventions
BIOLOGICALElderberry Juice
OTHERPlacebo
Sponsors
University of Missouri-Columbia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visuospatial Problem Solving Battery (VSP) | 12 wks, 6 mos | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mini-Mental State Examination (MMSE) | 12 wks, 6 mos | 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. |
| Hopkins Verbal Learning Test (HVLT) | 12 wks, 6 mos | 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. |
| Boston Naming Test (BNT) | 12 wks, 6 mos | Measures word retrieval. Change in the BNT is the primary outcome measure. The range is 0-60 with higher representing better performance. |
| Clinical Dementia Rating (CDR) Scale | 12 wks, 6 mos | 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. |
| Anagrams | 12 wks, 6 mos | 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. |
| Instrumental Activities of Daily Living Scale (IADLS) | 12 wks, 6 mos | 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. |
| Rey Complex Figure Task (Rey) | 12 wks, 6 mos | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Elderberry Juice Participants will drink 5ml of elderberry juice, diluted in 8oz of water, 3 times per day for three months.
Elderberry Juice | 11 |
| Placebo Participants will drink 5ml of colored water, diluted in 8oz of water, 3 times per day for three months.
Placebo | 13 |
| Total | 24 |
Baseline characteristics
| Characteristic | Total | Elderberry Juice | Placebo |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 23 Participants | 10 Participants | 13 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants | 1 Participants | 0 Participants |
| Age, Continuous | 76.33 years STANDARD_DEVIATION 6.95 | 76.45 years STANDARD_DEVIATION 8.47 | 76.23 years STANDARD_DEVIATION 7.73 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 24 Participants | 11 Participants | 13 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 24 Participants | 11 Participants | 13 Participants |
| Region of Enrollment United States | 24 Participants | 11 Participants | 13 Participants |
| Sex: Female, Male Female | 14 Participants | 8 Participants | 6 Participants |
| Sex: Female, Male Male | 10 Participants | 3 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 11 | 0 / 13 |
| other Total, other adverse events | 0 / 11 | 1 / 13 |
| serious Total, serious adverse events | 0 / 11 | 0 / 13 |
Outcome results
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.
Time frame: 12 wks, 6 mos
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Elderberry Juice | Visuospatial Problem Solving Battery (VSP) | 12 week change from baseline | .30 Mean Difference Score (VPS Total Score) | Standard Error 0.52 |
| Elderberry Juice | Visuospatial Problem Solving Battery (VSP) | 6 month change from baseline | .097 Mean Difference Score (VPS Total Score) | Standard Error 0.44 |
| Placebo | Visuospatial Problem Solving Battery (VSP) | 12 week change from baseline | .29 Mean Difference Score (VPS Total Score) | Standard Error 0.47 |
| Placebo | Visuospatial Problem Solving Battery (VSP) | 6 month change from baseline | .52 Mean Difference Score (VPS Total Score) | Standard Error 0.38 |
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.
Time frame: 12 wks, 6 mos
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Elderberry Juice | Anagrams | Change from baseline at 6 months | -.41 Mean Difference Score (Anagrams Total) | Standard Error 0.95 |
| Elderberry Juice | Anagrams | Change from baseline at 12 weeks | -1.81 Mean Difference Score (Anagrams Total) | Standard Error 0.13 |
| Placebo | Anagrams | Change from baseline at 6 months | 1.67 Mean Difference Score (Anagrams Total) | Standard Error 0.86 |
| Placebo | Anagrams | Change from baseline at 12 weeks | 2.70 Mean Difference Score (Anagrams Total) | Standard Error 0.99 |
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.
Time frame: 12 wks, 6 mos
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Elderberry Juice | Boston Naming Test (BNT) | Change from baseline at 12 weeks | 1.38 Mean Difference Score (BNT Total) | Standard Error 0.65 |
| Elderberry Juice | Boston Naming Test (BNT) | Change from baseline at 6 months | .96 Mean Difference Score (BNT Total) | Standard Error 0.54 |
| Placebo | Boston Naming Test (BNT) | Change from baseline at 12 weeks | .94 Mean Difference Score (BNT Total) | Standard Error 0.59 |
| Placebo | Boston Naming Test (BNT) | Change from baseline at 6 months | 1.60 Mean Difference Score (BNT Total) | Standard Error 0.49 |
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.
Time frame: 12 wks, 6 mos
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Elderberry Juice | Clinical Dementia Rating (CDR) Scale | Change from Baseline at 6 months | 0 Mean difference on CDR scale | Standard Error 0 |
| Elderberry Juice | Clinical Dementia Rating (CDR) Scale | Change from Baseline at 12 weeks | 0 Mean difference on CDR scale | Standard Error 0 |
| Placebo | Clinical Dementia Rating (CDR) Scale | Change from Baseline at 12 weeks | 0 Mean difference on CDR scale | Standard Error 0 |
| Placebo | Clinical Dementia Rating (CDR) Scale | Change from Baseline at 6 months | 0 Mean difference on CDR scale | Standard Error 0 |
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.
Time frame: 12 wks, 6 mos
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Elderberry Juice | Hopkins Verbal Learning Test (HVLT) | Change from baseline at 12 weeks | -.50 Mean Difference Score (HVL Free Recall) | Standard Error 0.43 |
| Elderberry Juice | Hopkins Verbal Learning Test (HVLT) | Change from baseline at 6 months | -19 Mean Difference Score (HVL Free Recall) | Standard Error 0.33 |
| Placebo | Hopkins Verbal Learning Test (HVLT) | Change from baseline at 12 weeks | .46 Mean Difference Score (HVL Free Recall) | Standard Error 0.4 |
| Placebo | Hopkins Verbal Learning Test (HVLT) | Change from baseline at 6 months | .27 Mean Difference Score (HVL Free Recall) | Standard Error 0.29 |
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.
Time frame: 12 wks, 6 mos
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Elderberry Juice | Instrumental Activities of Daily Living Scale (IADLS) | Change from baseline at 6 months | -30 Mean Difference Score (IADL) | Standard Error 0.66 |
| Elderberry Juice | Instrumental Activities of Daily Living Scale (IADLS) | Change from baseline at 12 weeks | .40 Mean Difference Score (IADL) | Standard Error 0.69 |
| Placebo | Instrumental Activities of Daily Living Scale (IADLS) | Change from baseline at 6 months | -44 Mean Difference Score (IADL) | Standard Error 0.6 |
| Placebo | Instrumental Activities of Daily Living Scale (IADLS) | Change from baseline at 12 weeks | -.34 Mean Difference Score (IADL) | Standard Error 0.59 |
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.
Time frame: 12 wks, 6 mos
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Elderberry Juice | Mini-Mental State Examination (MMSE) | Change from baseline at 12 weeks | .03 Mean Difference Score (MMSE) | Standard Error 0.73 |
| Elderberry Juice | Mini-Mental State Examination (MMSE) | Change from baseline at 6 months | -1.01 Mean Difference Score (MMSE) | Standard Error 0.9 |
| Placebo | Mini-Mental State Examination (MMSE) | Change from baseline at 12 weeks | .29 Mean Difference Score (MMSE) | Standard Error 0.66 |
| Placebo | Mini-Mental State Examination (MMSE) | Change from baseline at 6 months | .06 Mean Difference Score (MMSE) | Standard Error 0.82 |
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.
Time frame: 12 wks, 6 mos
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Elderberry Juice | Rey Complex Figure Task (Rey) | Change from baseline at 6 months | -.54 Mean Difference Score (REY Copy Score) | Standard Error 1.61 |
| Elderberry Juice | Rey Complex Figure Task (Rey) | Change from baseline at 12 weeks | -1.03 Mean Difference Score (REY Copy Score) | Standard Error 1.43 |
| Placebo | Rey Complex Figure Task (Rey) | Change from baseline at 12 weeks | 1.41 Mean Difference Score (REY Copy Score) | Standard Error 1.35 |
| Placebo | Rey Complex Figure Task (Rey) | Change from baseline at 6 months | -1.72 Mean Difference Score (REY Copy Score) | Standard Error 0.27 |