Objective:

2

To investigate the long-term therapeutic effects of the Chinese medicine Jiannao Yizhi Formula (健脑益智方

JYF) in the treatment of Alzheimer's disease (AD).

Methods:

2

Sixty mild-to-moderate AD participants were recruited and randomly allocated to the treatment (30 with JYF) and the control groups (30 with donepezil) for 6 months with the random numbers. The primary outcomes were scores of Alzheimer's Disease Rating Scale-Cognitive (ADAS-Cog) and Chinese Medicine Symptom Scale (CM-SS). The secondary outcomes were scores of Mini Mental State Examination (MMSE)

Montreal Cognitive Assessment (MoCA)

and Activities of Daily Living (ADL). Safety assessments were conducted at baseline and the 6th month of treatment. Serum levels of acetylcholine (Ach)

amyloid-β protein 42 (Aβ

42

)

and the microtubule-associated protein tau (Tau) were also determined by enzyme-liked immunosorbent assay.

Results:

2

Fifty-one participants were included in the final analyses (JYF

n

=27; donepezil

n

=24). Compared with baseline

both JYF and donepezil increased the MoCA and MMSE scores and decreased the ADAS-Cog and CM-SS scores (

P

<

0.05 or

P

<

0.01). Both drugs increased the serum levels of Ach and decreased the serum levels of Aβ

42

and Tau (all

P

<

0.05). There was no significant difference in these variables between the two groups

which showed that JYF was not inferior to donepezil. No obviously significant changes were observed in the ADL. No severe adverse events were observed in both groups.

Conclusion:

2

The effect and safety of JYF for the treatment of AD were not inferior to those of donepezil.