N/A
Completed N=12
Effect of Blueberry Supplementation on Alzheimer's Biomarkers
Source: ClinicalTrials.gov NCT05172128 ↗Enrolled (actual)
12
Serious AEs
10.0%
Results posted
Sep 2024
Primary outcomePrimary: Change in Blood Neurofilament Light (NfL) Levels as Measured by Blood Biomarker Assay — 30.09; 44.25 pg/mL — p=>0.05
Summary
The purpose of this study is to study the effects of blueberries on neuronal, glial, and pathology blood biomarkers in Mild Cognitive Impairment (MCI) and to estimate sample size for future confirmatory studies. The blood biomarkers to be measured are Neurofilament light (NfL), glial fibrillary acidic protein (GFAP), Aß40, Aß42, p-tau181, and cytokines, using an ultra-sensitive state-of-the-art immunoassay.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Blood Neurofilament Light (NfL) Levels as Measured by Blood Biomarker Assay |
30.09; 44.25 | >0.05 |
| PRIMARY Change in Blood Glial Fibrillary Acidic Protein (GFAP) Levels as Measured by Blood Biomarker Assay |
239.86; 234.27 | >0.05 |
| PRIMARY Change in Blood Amyloid Beta 42/40 as Measured by Blood Biomarker Assay |
.050; .050 | >0.05 |
| PRIMARY Change in P-tau 181 as Measured by Blood Biomarker Assay |
37.24; 38.04 | >0.05 |
| PRIMARY Change in Blood Interleukin-6 (IL-6) Levels as Measured by Blood Biomarker Assay |
— | — |
| PRIMARY Change in Tumor Necrosis Factor (TNF-alpha) Levels as Measured by Blood Biomarker Assay |
— | — |
| PRIMARY Change in Brain-derived Neurotrophic Factor (BDNF) |
1685.48; 1850.15 | >0.05 |
Eligibility Criteria
Inclusion Criteria
- 55 to 85 years old inclusive
- Meets criteria for amnestic Mild Cognitive Impairment defined by education adjusted performance on the Wechsler Memory Scale (WMS) III Logical Memory delayed recall score and clinical evaluation.
- Medically stable
Exclusion Criteria
- Dementia
- Significant confounding active neurological/psychiatric disease
- Participation in an experimental investigational drug trial in the past 30 days
- Unwilling to restrict consumption of anthocyanin-rich foods
- Inability to complete cognitive testing (e.g. significant visual or hearing impairment)
- Allergy or intolerance to blueberries
- Significant gastrointestinal disorders or surgery that influences digestion and absorption
- Presence of unstable, acutely symptomatic, or life-limiting illness
- Women of childbearing potential
Data sourced from ClinicalTrials.gov (NCT05172128). 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.