P652
Poster Presentations: P3
Methods: To date, 137 participants were randomized into an online-only (n¼46), online+face-to-face (n¼45), or an active control group (n¼46). Participants underwent a comprehensive baseline evaluation prior to randomization which included the assessment of AD risk profile with our validated ANU-Alzheimer’s disease risk index (ANU-ADRI, Anstey et al. 2013), as well as a psychological, cognitive, and physical examination, and optional blood tests. Participants were evaluated again immediately following the 12-week intervention, and 3 months later. Results: Selected sample characteristics are listed in Table 1. Overall, 132 participants (96.4%) had at least two risk factors and/or fewer than two protective factors. The most prevalent risk factor (66.2%) was overweight or obese BMI and the least prevalent protective factor (39%) was cognitive activity. The sample was in the healthy range on all cognitive measures. No differences between the three groups were observed on any of the demographic, lifestyle, medical or cognitive measures. Conclusions: Baseline data confirms that the sample is cognitively healthy, and that it has on average three AD-risk factors. Successful randomization was demonstrated by showing that no group differences existed on any of the baseline characteristics that may influence outcomes. Final follow up data are expected by September 2013 and will show whether the intervention is associated with a reduced AD-risk profile. If successful, the findings will contribute to the development of further dementia risk reduction interventions.Long term follow-up studies are required to examine whether reduction in exposure to dementia risk factors will be associated with reduced prevalence.
P3-262
2 Seoul National University, Seoul, South Korea; 3Seoul National University Hospital, Seoul, South Korea; 4Department of Neuropsychiatry, Seoul, South Korea. Contact e-mail:
[email protected]
Background: This study aimed to evaluate preliminary effects of a 8-week multi-components cognitive intervention program on the daily activities, cognition and psychosocial wellbeing of the patients with mild cognitive impairment (MCI) and their family partners’ perceived caregiver burden and mood. Methods: Fourteen MCI patients (6 or more years of formal education) and their family partners received the 8-week multi-components cognitive intervention program. MCI participants were assessed on primary measures of goal oriented everyday activities (Canadian Measure of Occupational Performance, perceived performance and satisfaction) and cognitions (ADAS-K-cog) at three different time points during the program (pre-, post-, and 3 months after intervention). In addition, psychosocial components and the family partners’ perceived caregiver burden and mood were also measured. Data were analyzed to evaluate the immediate effects (changes between pre- and post-intervention), and delayed effects (changes between pre- and 3 months post-intervention). Results: Eleven MCI pa-
OPTIMIZING REHABILITATION IN DEMENTIA WITH ACUTE ILLNESS: PROJECT PERFECTED
Chris Fox1, Ian Maidment2, Jane Cross3, Fiona Poland4, Toby Smith4, Bridget Penhale3, Opinder Sahota5, Malaz Boustani6, 1University of East Anglia Medical School, Norfolk, United Kingdom; 2Aston University, Birmingham, United Kingdom; 3University of East Anglia, Norwich, United Kingdom; 4Allied Health Professional, Norwich, United Kingdom; 5 Nottingham University, Nottingham, United Kingdom; 6Indiana University School of Medicine, Indianapolis, Indiana, United States. Contact e-mail:
[email protected] Background: With global levels of dementia predicted at 1.4 billion by 2040 (HSBC 2009) and increasing levels of multimorbidity in these patients there is a need to develop new strategies to reduce the impact of multimorbidity (Lin 2013). These patients constitute half of the costs of all co-morbidity patients (Lin 2009). In the UK up to 50% of hospital beds are occupied by patients with dementia. The PERFECTED project is an international project which will develop a template for a trackable and comprehensive rehabilitation pathway for patients with dementia who develop acute illness in this case hip fracture with its associated complications. Methods: Systematic literature review of assessment validated in this this patient groups and consideration of methodological challenges for optimal rehabilitation management. Results: There are valid and reliable assessment tools for delirium and pain in dementia. There is a need to develop/adapt dementia relevant assessment tools. We will present a summary of key issues on rehabilitation which are derived from initial stages of this project. In addition audience participation will enhance the pathway construction. Conclusions: There is evidence of potential for rehabilitation for people with dementia and acute illness in hospital. The economic and health benefits are potentially enormous in different health care settings.
P3-263
PRELIMINARY EVALUATION OF A MULTICOMPONENT COGNITIVE INTERVENTION PROGRAM FOR PEOPLE WITH AMNESTIC MILD COGNITIVE IMPAIRMENT AND THEIR FAMILY PARTNERS
Kyoungmin Lee1, Dong Young Lee2, Bo Kyung Sohn3, Young Min Choe4, Jong Inn Woo1, 1Seoul National University Hospital, Seoul, South Korea;
Figure. An Example of the MCI program
Table 1 Characteristics of participants Variable
Level
Patients with MCI N¼11
Family carers Number¼11
Male Female
6 (54.6) 5 (45.5)
3 (27.3) 8 (72.7)
Less than 59 60 w 69 4 (36.4) 70 w 79 5 (45.5) 80 w 89 2 (18.2)
3 (27.3) 3 (27.3) 2 (18.2) 3 (27.3)
6w9 10 w 12 13 w16 Above 17
5 (45.5) 4 (36.4) 2 (18.2)
Gender (No, %)
Age (No, %)
Level of Education (year) 4 (36.4) 3 (27.3) 2 (18.2) 2 (18.2)
Relationship With the patient Wife Husband Daughter
6 (54.5) 3 (27.3) 2 (18.2)
Poster Presentations: P3 Table 2 Outcomes of everyday activities scores, cognition, depression Post intervention Follow-up Pre-intervention mean mean mean score (SD) score (SD) score (SD)
Measure Patients with MCI COPM mean overall ratings Performance (max 10)*1,*2 Satisfaction (max 10)*1,*2 ADAS-K-Cog (max 70) MMSE-KC (max 30) S-IADL Performance (max 45) Potential (max 45) QOL-AD(self) (max 52) QOL-AD(family) (max 52) GDS-kr (max 30)*1 Family carers Burden Index (max 88) CES-D (max 60)
4.6 (1.82) 5.2 (1.39) 10.2 (3.55) 24.9 2.34)
5.7 (1.35) 5.9 (1.26) 6.1 (1.55) 6.3 (1.46) 9.8 (4.98) 9.6 (4.88) 24.8 (3.19) 24.8 (2.48)
13.7 (4.88) 11.3 (4.74) 30.4 (4.97) 30.9 (3.45) 12.5 (7.49)
11.2 (5.98) 9.5 (5.70) 32.3 (5.52) 33.2 (5.36) 9.8 (5.21)
20.8 ( 6.48) 13.3 (14.70)
23.0 (10.14) 21.7 (13.61) 12.0 (16.06) 11.8 (11.98)
13.6 (4.86) 10.6 (5.95) 32.2 (6.19) 32.9 (6.61) 11.1 (7.41)
COPM, Korean version of Canadian occupational performance measure; ADAS-K-Cog Alzheimer’s Disease Assessment Scale-Korean-Cognition; S-IADL, Seoul - Instrumental Activities of Daily Living, GDS-Kr, Geriatric Depression Scale-Korean version; QOL-AD, Quality of Life - Alzheimer’s Disease; CES-D, Center for Epidemiological Studies - Depression Scale) 1 Comparison between baseline and post-program by paired t-test 2 Comparison between baseline and 3 months post-program by paired t-test *P<0.5. tients (5 women, 6 men; mean age¼71.9 years, standard deviation¼ 7.6, range ¼ 61w 86) and their family partner completed the whole intervention. Patients showed significant improvement in ratings of goal performance (immediate effect p ¼015, delayed effect p ¼.049) and satisfaction (immediate p ¼0.005, delayed p ¼.015), whereas scores on cognition remained unchanged. Patient’s depression improved right after the intervention (p ¼0.049), but delayed effect was not confirmed (p ¼.341). IADL functioning measured with S-IADL, and Quality of life measure with the QOL-AD seemed improved, but they were not significant. Family partners’ caregiver burden and mood were unchanged. Conclusions: The results implicates that our multi-components cognitive intervention specially designed for MCI patients and their family partners could be helpful for goal-oriented everyday activities and patients’ mood.
P3-264
SEPARATION OF DRUG EFFECT FROM PLACEBO CONTROL IN ALZHEIMER’S DISEASE TRIALS: IMPROVING THE CHANCES
David Miller1, Amanda Young1, Priscilla Samuelson1, David Henley2, Gopalan Sethuraman2, Karen Sundell2, 1Bracket, Wayne, Pennsylvania, United States; 2Eli Lilly, Indianapolis, Indiana, United States. Contact e-mail:
[email protected] Background: The ultimate goal of any clinical trial is drug-placebo separation at study endpoint. This can be challenging in Alzheimer’s disease (AD) clinical trials - particularly those that assess disease modifying drugs - as they tend to be longer, multi-national, and have more rater turnover and drift. Additionally, there is a greater likelihood of encountering potential raters whose experience with the primary efficacy instruments falls below the desired level. Previous research has shown that an enriched training curriculum coupled with an in-study ratings reliability program can enable these raters to both certify to participate, and perform comparably to their more experienced colleagues. Additionally, such a program has been shown to significantly decrease the frequency of rater errors over the course of a trial.
P653
Methods: Data from 582 subjects in 2 of 4 AD trials previously discussed were available for analysis. The quality of the co-primary endpoint (ADASCog) administration and scoring was evaluated at Baseline and Week 52 as part of an in-study ratings reliability program. Further analysis was performed to determine if raters were able to separate drug from placebo at study endpoint (Week 76). Results: As previously reported, at 52 weeks, all raters, regardless of whether they were inexperienced and required enriched training or were experienced prior to the study, trended toward separating drug from placebo treatment on the ADAS-Cog. An additional analysis examining drug-placebo separation at week 76 via a difference of LS means methodology, also found a trend (Pr ¼ 0.0864) toward separation, with drug treated subjects performing worse on the ADAS-Cog compared to placebo treated subjects. Conclusions: In longer, multi-national disease modifying studies of AD, rater performance can be affected by variable experience with the scales and rater drift. An enriched training curriculum for less experienced raters coupled with an in-study ratings reliability program for all raters improved scale rating performance at study endpoint.
P3-265
ATYPICAL ANTIPSYCHOTIC EFFICACY AND TOLERABILITY IN DEMENTIA SUBJECTS LIVING AT A LONG-TERM CARE FACILITY: A RETROSPECTIVE STUDY
Douglas Scharre1, Shu-ing Chang1, Haikady Nagaraja1, Michael Merjanian1, Gail Greenley2, Rebecca Davis1, 1Ohio State University, Columbus, Ohio, United States; 2Forest Hills Center, Columbus, Ohio, United States. Contact e-mail:
[email protected] Background: The effectiveness and tolerability of atypical antipsychotics in dementia patients have been mostly studied in outpatient settings like the CATIE-AD investigation, which concluded that adverse events offset the efficacy advantages. Since dementia residents in long-term care facilities are significantly more cognitively impaired and behavioral disturbed, further study in this population is warranted. Methods: Residents at an all-dementia long-term care facility with primary neurodegenerative dementia, no other major psychiatric disorder, and psychotic related behaviors significant enough to warrant atypical antipsychotic treatment despite non-pharmacological management, all managed by a single clinician (DWS) were retrospectively studied. We used a baseline severity behavior scale of 1-6 describing clinically distinct behavioral subtypes. Group 1¼no significant behavioral issues; 2¼psychosis without agitation; 3¼psychosis with provoked agitation; 4¼psychosis with intermittent self-initiated/unprovoked agitation; 5¼psychosis with continuous self-initiated/unprovoked verbal agitation; 6¼psychosis with continuous self-initiated/unprovoked physical agitation. The Clinical Global Impression (CGI) scale (1-7) was assessed at every visit after initiation of the antipsychotic to determine efficacy of the atypical antipsychotic over time. Psychotic behaviors successfully treated with atypical antipsychotics were defined as a duration-weighted average CGI score of very much improved or much improved (1 or 2). We recorded antipsychotic dose, duration and tolerability data. Results: All patients meeting inclusion/exclusion criteria from May 2006 to August 2012 were included. Ninety-nine subjects are age (78.3 + 7.9 years), female/male (53/46), education 1 3.1 + 3.9 years, and white/nonwhite (82/ 17). 93% of residents in baseline severity behavior groups 4-6 (n¼61) were successfully treated with atypical antipsychotics (CGI<3), which was significantly better (p¼0.025) than 74% of residents in baseline severity behavior groups 2 and 3 (n¼38). The average dose per day was 83646 mg for quetiapine (n¼75), 72636 mg for ziprasidone (n¼13), and 0.9260.43 mg for risperidone (n¼8). Sleepiness (17/99) was the most common adverse effect. Weight gain >10% (4/99), EPS (2/99), glucose intolerance (4/99), and dyslipidemia (5/99) were noted. Conclusions: Atypical antipsychotics used in appropriate doses for psychosis with and without agitation combined with non-pharmacological management, were highly effective and extremely well tolerated in this population. Despite black-box warnings, these medications should not be discouraged in this setting. Further prospective study is urged.