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P1‐068: ANALYSIS OF THE RATES AND TYPES OF ERRORS ON ENHANCED ECOA VERSIONS OF THE ALZHEIMER'S DISEASE ASSESSMENT SCALE‐COGNITIVE SUBSCALE AND MINI MENTAL STATE EXAMINATION USED IN CLINICAL TRIALS OF DEMENTIA
Author(s) -
Solomon Todd M.,
Karas Sarah M.,
Barbone Jordan M.,
DiGregorio Danielle T.,
Miller David S.,
Feaster H. Todd
Publication year - 2018
Publication title -
alzheimer's and dementia
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 6.713
H-Index - 118
eISSN - 1552-5279
pISSN - 1552-5260
DOI - 10.1016/j.jalz.2018.06.070
Subject(s) - clinical trial , dementia , scale (ratio) , cognition , mini–mental state examination , cognitive impairment , psychology , disease , medicine , psychiatry , cartography , geography
outcome measures were changes from baseline in the Vascular Dementia Assessment Scale-Cognitive Subscale(VADAS-cog) and neuropsychiatric Inventory(NPI) after 24 weeks treatment. The secondary outcomes were changes from baseline in the Clinician’s Interview-Based Impression of Change-Plus care Interview(CIBIC-plus),mini-mental state examination(MMSE), activity of daily living scale(ADL) ,clock drawing test(CDT), trail making test (TMT), hyperactivity of Liver Yang scale(HLY, a syndrome defined by traditional Chinese medicine). Results: The VADAS-cog showed a significant improvement in TZ and donepezil groups at the endpoint (mean change, 6.20(95% CI:5.31w7.09) in TZ group, 6.53(95% CI:5.63w7.4) in donepezil group, 3.47(95% CI:1.76w5.19) in placebo group, all p<0.001 for the comparison with placebo)(Figure 1).NPI showed modest improvement from baseline in TZ(-3.0364.84) and donepezil (-2.2165.45) compared to placebo(-0.3665.70) (P<0.001,P1⁄40.013 compared to placebo) (Figure 2).There was significant difference on the improvement percent of the CIBIC-plus between three groups( 73.71% in TZ group, 79.83% in donepezil group, 58.18% in placebo group, all p<0.001 compared with placebo) . There was no significant difference of TZ in the changes of VADAS-cog and CIBIC-plus from donepezil group. The HLY scale showed significant improvement in the TZ group than placebo group(P1⁄40.034). The change of HLY in the TZ group was significantly correlated to the changes of VADAS-cog(r1⁄40.16,p<0.001) and NPI(r1⁄40.24, p<0.001). No benefits obtained in the three groups on ADL, CDT, and TMT-B. The frequency of adverse events was no significant difference between three groups. Conclusions: In patients with mild to moderate VaD, TZ showed significant benefits with cognition, behavioral and psychological symptoms. TZ did not improve functional ability. NCT02453932. P1-067 AMBROXOL AS PHARMACOLOGICAL CHAPERONE TARGETING GBA1 AS A DISEASE MODIFYING TREATMENT FOR PARKINSON’S DISEASE DEMENTIA: A PHASE 2 RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL Stephen H. Pasternak, Carolina Silveira, Zhonghan Li, Robert Bartha, Michael Borrie, Jennie Wells, Penny MacDonald, Guangyoug Zou, Mary Jenkins, Elizabeth Finger, Mandar Jog, Tony Rupar, Rommel Tirona, Robarts Research Institute, London, ON, Canada; Western University, London, ON, Canada; Parkwood Institute, London, ON, Canada; Parkwood Institute, St Joseph’s Health Care Centre, London, ON, Canada. Contact e-mail: spasternak@robarts.ca