N/A N=12 Basic Science

Effect of Blueberry Supplementation on Alzheimer's Biomarkers

Mild Cognitive Impairment · Alzheimer Disease

Bottom Line

View on ClinicalTrials.gov: NCT05172128 ↗

Enrolled (actual)

Serious AEs

10.0%

Results posted

Sep 2024

Primary outcome: Primary: Change in Blood Neurofilament Light (NfL) Levels as Measured by Blood Biomarker Assay — 30.09; 44.25 pg/mL — p=>0.05

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: lyophilized blueberry supplement (Dietary_supplement)
Age: Adult, Older Adult · 55+ yrs
Sex: All
Sponsor: Duke University
Primary completion: Feb 2023

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

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.

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

View full record on ClinicalTrials.gov →

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.