1000 Section - Effects of JianNao TongLuo Granules on Cognition and Prefrontal Activation in Mild Cognitive Impairment: A Randomized Double-Blind Trial

To evaluate whether JianNao TongLuo granules (JNTL), a Chinese herbal formula, improve cognitive and related functional outcomes in older adults with mild cognitive impairment (MCI), and to determine whether these clinical effects are accompanied by changes in task-evoked prefrontal activation measured by functional near-infrared spectroscopy (fNIRS).

Design:

We conducted a 12-week randomized, double-blind, placebo-controlled trial in adults with MCI. Sixty-four participants were allocated 1:1 to receive JNTL or matching placebo in addition to usual care. Global cognition was assessed with the Montreal Cognitive Assessment (MoCA), and executive function with the Shape Trail Test (STT-A/B). Sleep and depressive symptoms were measured using the Pittsburgh Sleep Quality Index and Patient Health Questionnaire-9. Task-related prefrontal activation during a verbal fluency task was recorded with multichannel fNIRS, and beta values for oxyhemoglobin changes were derived using a general linear model. Group differences in change from baseline were analyzed using linear models adjusting for baseline scores.

Results:

Compared with placebo, the JNTL group showed greater improvement in MoCA scores (between-group mean difference 3.16, 95% CI 1.99–4.33, p< 0.001) and shorter STT-B completion times, indicating better executive function (p< 0.01). Sleep quality and depressive symptoms also improved more in the JNTL group. fNIRS revealed significantly increased task-evoked oxyhemoglobin responses in several channels over the left inferior frontal gyrus (Broca’s area) after JNTL treatment, whereas changes were minimal with placebo. No treatment-related adverse events were observed.

Conclusion:

JNTL improved global cognition, executive function and related symptoms in older adults with MCI and enhanced task-evoked activation of the left prefrontal cortex. These findings suggest that modulation of prefrontal networks may be an important mechanism underlying the cognitive benefits of this multi-target Chinese medicine intervention. JNTL may represent a promising adjunct to neurorehabilitation strategies for MCI, and its effects should be confirmed in larger and longer trials.