We found a match
Your institution may have rights to this item. Sign in to continue.
- Title
Efficacy and safety of a novel acetylcholinesterase inhibitor octohydroaminoacridine in mild-tomoderate Alzheimer's disease: a Phase II multicenter randomised controlled trial.
- Authors
SHIFU XIAO; TAO WANG; XIUQIANG MA; YINGYI QIN; XIA LI; ZHONGXIN ZHAO; XUEYUAN LIU; XIAOPING WANG; HENGGE XIE; QINPU JIANG; LI SUN; BENYAN LUO; LAN SHANG; WEIXIAN CHEN; YAN BAI; MUNI TANG; MAOLIN HE; LAN WU; QILIN MA; DEREN HOU
- Abstract
Background: inhibition of acetylcholinesterase (AChE) has been a effective treatment for Alzheimer's disease (AD). Octohydroaminoacridine, a new AChE inhibitor, is a potential treatment for AD. Method: we conducted a multicenter, randomised, double blind, placebo-controlled, parallel-group Phase II clinical trial to investigate the effects of octohydroaminoacridine in patients with mild-to-moderate AD. Patients were randomised to receive placebo thrice daily, octohydroaminoacridine 1 mg/thrice daily (TID) (low-dose group), 2 mg/TID (middle-dose group) or 4 mg/TID (high-dose group). Doses in the middle-dose and high-dose group were titrated over 2-4 weeks. Changes from baseline to Week 16 were assessed with the AD Assessment Scale-Cognitive Subscale (ADAS-cog), Clinician's Interview-Based Impression of Change Plus (CIBIC+), activities of daily living (ADL) and the neuropsychiatric inventory (NPI). ADAS-cog was the primary end point of the study. A two-way analysis of covariance and least squares mean t-test were used. Results: at Week 16, the changes from baseline in ADAS-cog were 1.4, -2.1, -2.2 and -4.2 for placebo, low-, middle- and high-dose groups, respectively. Patients in the high-dose group had better performance in CIBIC+ and ADL scores at the end of the study. There was no significant difference in the change in NPI score among the groups. The effects of octohydroaminoacridine were dose dependent, and were effective within 16 weeks of treatment. No evidence was found for more adverse events that occurred in different drug groups than placebo group. Conclusions: octohydroaminoacridine significantly improved cognitive function and behaviour in patients with mild-tomoderate AD and this effect was dose dependent.
- Subjects
ALZHEIMER'S disease; ANALYSIS of covariance; DOSE-effect relationship in pharmacology; MEDICAL cooperation; PARASYMPATHOMIMETIC agents; PATIENT safety; PLACEBOS; RESEARCH; STATISTICAL sampling; T-test (Statistics); RANDOMIZED controlled trials; TREATMENT effectiveness; BLIND experiment; DESCRIPTIVE statistics; THERAPEUTICS
- Publication
Age & Ageing, 2017, Vol 46, Issue 5, p767
- ISSN
0002-0729
- Publication type
Article
- DOI
10.1093/ageing/afx045