Effect of Probiotic Bifidobacterium breve in Improving Cognitive Function and Preventing Brain Atrophy in Older Patients with Suspected Mild Cognitive Impairment: Results of a 24-Week Randomized, Double-Blind, Placebo-Controlled Trial

Journal of Alzheimer's Disease
Q1
May 2022
Citations:84
Influential Citations:6
Interventional (Human) Studies
93
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Enhanced Details

Methods
Randomized, double-blind, placebo-controlled trial in older adults with suspected MCI; 130 participants aged 65–88 years; DSM-5 criteria for MCI; MMSE 22–26; CDR 0.5; conducted in Tokyo, Japan; outcomes included ADAS-Jcog, MMSE, and MRI with VSRAD.
Intervention
Bifidobacterium breve MCC1274, 2×10^10 CFU per sachet, taken once daily for 24 weeks; oral administration.
Results
Total ADAS-Jcog and MMSE scores did not differ between probiotic and placebo. Orientation improved at 24 weeks with MCC1274 (ADAS-Jcog orientation, p=0.021); MMSE orientation in time improved in participants with baseline MMSE <25 (p=0.006). In MMSE <25, ADAS-Jcog orientation improved (p=0.022). In MMSE ≥25, minor improvements in ADAS-Jcog construction (p=0.021) and MMSE writing (p=0.036). A modified MMSE (excluding Serial-7) showed total MMSE improvement at week 16 in MMSE <25 (p=0.011). MRI (VSRAD) indicated slower brain atrophy progression with MCC1274; GM extent difference between groups (p=0.013); in baseline VOI Z-score ≥1.0 subgroup, progression was less favorable in MCC1274. Gut microbiota changes were limited. Adherence was high; no treatment-related adverse events. Conclusion: 24 weeks of MCC1274 may help prevent cognitive impairment progression in MCI by improving select cognitive domains and slowing brain atrophy; overall cognition did not improve; regimen appears feasible and safe, warranting further study.
Limitations
COVID-19 reduced the planned sample size (from 140 to 130); 115 completed the Full Analysis Set; many findings are subgroup analyses and may be underpowered; generalizability limited to Japanese older adults with MCI; RBANS was not used; long-term effects unknown.

Abstract

Background: Probiotics have been reported to ameliorate cognitive impairment. Objective: We investigated the effect of the probiotic strain Bifidobacterium breve MCC1274 (A1) in enhancing cognition and preventing brain atrophy of older patients with ...