Podium Presentations: Sunday, July 16, 2017 S1-02-04 NEURODEGENERATIVE PATHOBIOLOGY IN PRECLINICAL MODELS OF REPETITIVE MILD TRAUMATIC BRAIN INJURY Fiona Crawford, Roskamp Institute, Sarasota, FL, USA. Contact e-mail: fcrawford@rfdn.org P171 intervention reduced cost compared to treatment as usual, and the benefits achieved were therefore associated with a cost saving. Conclusions: This is the largest RCT of a non-pharmacological intervention for people with dementia in nursing homes. WHELD conferred improvements in agitation and in quality of life amongst individuals with agitation, over 9 months and reduced cost. WHELD therefore has a number of advantages compared to pharmacological treatments currently used to treat agitation. Abstract not available. SUNDAY, JULY 16, 2017 FEATURED RESEARCH SESSION F1-01 ECOPSYCHOSOCIAL TREATMENT OF ALZHEIMER?S DISEASE AND RELATED DEMENTIAS: CURRENT ADVANCES F1-01-01 IMPACT OF WHELD INTERVENTION ON NEUROPSYCHIATRIC SYMPTOMS, ANTIPSYCHOTIC USE AND QUALITY OF LIFE IN PEOPLE WITH DEMENTIA LIVING IN NURSING HOMES: A CLUSTERRANDOMIZED TRIAL Clive Ballard1, Jane Fossey2, Anne Corbett1, Martin Orrell3, Renee Romeo4, Esme Moniz-Cook5, Bob Woods6, Rhiannon Whitaker7, 1 University of Exeter Medical School, Exeter, United Kingdom; 2Oxford Health NHS Trust, Oxford, United Kingdom; 3Institute of Mental Health, Faculty of Medicine & Health Sciences, University of Nottingham, Nottingham, United Kingdom; 4King?s College London, London, United Kingdom; 5Institute of Rehabilitation, Dementia Applied Research Centre, University of Hull, Hull, United Kingdom; 6Institute of Medical and Social Care Research, Bangor University, Bangor, United Kingdom; 7Whitaker Research Ltd, Bangor, United Kingdom. Contact e-mail: c.ballard@exeter. ac.uk Background: Agitation is a common and distressing symptom affecting large numbers of people with dementia and impacting significantly on quality of life. In the absence of safe, effective pharmacological therapies there is a need for evidence-based, cost-effective first-line non-drug treatments. A factorial study has enabled us to optimize the intervention, which we have now evaluated in a large cluster RCT. Methods: Design: A randomized controlled cluster trial comparing the WHELD intervention with treatment as usual in 69 UK nursing homes Participants: Nursing home residents with dementia Intervention: All nursing homes receiving the WHELD intervention received staff training in person-centered care (PCC), social interaction (SoI) and antipsychotic review (AR) followed by ongoing delivery through a care staff champion model. Main Outcome Measures: Quality of life (DEMQOL-proxy), agitation (Cohen Mansfield Agitation Inventory), neuropsychiatric symptoms (NPI), antipsychotic use and pain (Abbey Pain Scale). Results: Are presented as weight mean difference in change with 95% Confidence Intervals (CI). Intervention costs were calculated using published cost function figures and compared with usual costs. Results: 971 people were randomized to WHELD or treatment as usual. WHELD conferred a significant improvement in agitation (CMAI 8.63 95% CI 1.06 to 16.19, p�025). There was also a numerical non-significant benefit in quality of life (DEMQOL proxy 10.93 95% CI -2.82 to 24.68, p�12), which became significant in people with agitation (DEMQOL proxy 16.56 95% CI 0.35-32.78, p�045). An exploratory analysis showed benefit in the participants with moderate or severe pain at baseline (Abbey Pain Scale 2.93 95% CI -2.46 -.49, p�003). Antipsychotic drug prescribing was stable in both treatment groups. The WHELD F1-01-02 THE IMPACT OF ENVIRONMENTAL FACTORS ON ENGAGEMENT AND MOOD OF PERSONS WITH DEMENTIA ATTENDING RECREATIONAL GROUPS Jiska Cohen-Mansfield, School of Public Health, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel. Contact e-mail: jiska@post. tau.ac.il Background: Nonpharmacological interventions aim to address the needs of persons with dementia thereby improving their quality of life and preventing or reducing behavioral symptoms. Such needs include social contact and engagement with meaningful activities. Because prior research has shown that social activities are the most engaging for persons with dementia, we studied the impact of group activities in this population. In this study, we examined the impact of group topic and environmental factors on engagement and mood of persons attending recreational groups. Methods: Participants were 69 nursing home residents with dementia with an average score of 4.19 on the Cognitive Performance Scale (1糹ntact and 6約everely impaired). All were invited to two rounds of ten activity topics (e.g., singing) in their units. Therapeutic recreation staff members who ran the groups and research observers independently rated participants? level of engagement, active participation, attitude towards the activity and positive mood during group activities and non-group control conditions. Additionally, the time of day during which group activities were held and the groups? sizes were recorded, and temperature, light, and noise were rated. Background variables and level of cognitive function were taken from the MDS-2 in participants? health record. Results: Significantly higher ratings of participants? engagement and positive mood were observed during group activities than during the control observations ? according to both research and therapeutic recreation staff (all p<.001). Cognitive functioning was significantly related to all outcome variables and served as a covariate in all analyses of environmental factors (p<.001). Group content was a significant predictor of all outcome variables (p<.001). Loud background noise and small group size were associated with significantly worse outcomes in some of the analyses (p ranging between ns to p<.001). Conclusions: The results support the importance of groups for persons with dementia. They also highlight the role of some environmental factors (e.g., designing space that would minimize external noise) in optimizing group activities for this population. Such groups should form a basis for nonpharmacological interventions for persons with dementia. F1-01-03 CREATING PERSON-CENTERED ENVIRONMENTS AS TREATMENT FOR DEMENTIA Cameron Camp, Center for Applied Research in Dementia, Solon, OH, USA. Contact e-mail: cameron@cen4ard.com Background: Person-centered care for dementia faces challenges in its tranlsation into actual practice, including: 1) assessment that P172 Podium Presentations: Sunday, July 16, 2017 Table 1 Montessori Assessment System (MAS) Psychometric Properties Reliability The Cronbach alpha coefficient for the MAS � (a � 0.85). The item-total correlations for the 8 subscales of the MAS ranged from 0.62 to 0.94, with a mean of 0.79. Principal component analysis There were no outliers and no apparent problems with restriction of range. Bartlett test of sphericity (c2 �35.8; df 28; p < 0.001) and KaiserMeyer-Olkin measure of sampling adequacy (0.90) indicate MAS data matrix is very well suited to principal component analysis. One unique principal component that explained 66.7% of score variance was found with factor loadings Ranging from 0.66 to 0.92, with a mean of 0.81. Convergent validity MAS total score correlation with the Mini-Mental Status Examination (MMSE) (r � 0.67); with the Severe Impairment Battery (SIB-S)(r � 0.81) Discriminant validity MAS total score with age (r � 0.04); length of institutionalization (r � 0.07); education (r � 0.16). gender (t � -0.87, p � 0.38). No significant effects. Test-retest reliability N � 72; 15-day interval; r � 0.90 Inter-rater reliability N � 53; The intra-class correlation coefficient for inter-rater reliability � 0.95 emphasizes detection of deficits, and 2) responsive behaviors that subsume extensive time and attention of caregivers. Methods: Using Montessori-based activities for strength-based assessment of persons with dementia has been documented as a means of creating Table 2 Percent (%) reduction in use of medications wandering, agitation, and employee turnover before (1 year) and after (1 year) of Memory in Rhythm (MIR) program in memory units of Skilled Nursing Facilities (SNFs) and Assisted Living (AL) residences in the United States Medication Type Fmployee #Residents Center Anti- AntiPsyc Anx AntiDep Hypnotics Wandering Agitation Turnover SNF1 SNF2 SNF3 SNF4 SNF5 SNF6 SNF7 SNF8 SNF9 Average ALI AL2 AL3 AL4 AL5 AL6 AL7 Average 78 75 76 78 46 56 30 50 55 60 60 58 20 60 60 60 42 53 42 40 32 41 21 32 15 35 30 32 40 35 15 41 45 46 60 40 79 76 72 73 42 51 25 48 50 57 55 55 20 58 59 60 65 53 100 100 100 100 90 89 70 95 100 94 100 100 90 100 100 100 100 98 Anti-Psyc, antipsychotic medication; Anti-Anx, antianxiety medication; Anti-Dep, antidepressant medication 85 85 87 79 86 75 72 88 89 83 75 95 85 87 90 91 87 87 85 85 89 86 88 76 73 90 90 85 80 95 85 90 90 92 90 89 31 31 15 10 15 15 15 20 42 22 15 12 12 15 15 15 15 14 12 14 60 12 20 12 24 10 12 12 10 8 30 15 15 15 Table 3 Percent (%) increase of residents showing weight gain, residents who began sleeping at night, and % census ? number of residents in the memory unit increase; eating (# of residents regaining ability to feed themselves), and ADLs (# of residents who regained/improved one ADL), in the year after the Memory in Rhythm (MIR) program in comparison with the prior year in memory units of Skilled Nursing Facilities (SNFs) and Assisted Living (AL) residences in the U.S Center Weight Gain Sleeping Census Eating ADIs #Residents SNF1 SNF2 SNF3 SNF4 SNF5 SNF6 SNF7 SNF8 SNF9 Average AL1 AL2 AL3 AL4 AL5 AL6 AL7 Average 100 100 99 95 96 81 80 95 85 92 89 98 90 92 95 97 92 93 90 90 97 95 89 82 80 92 90 89 80 98 85 90 95 98 85 90 20 20 26 29 15 15 15 25 14 20 25 67 75 15 10 10 87 41 2 3 8 2 4 2 6 1 2 3 2 0 1 4 2 2 2 2 12 7 36 8 10 2 12 5 8 11 6 10 6 15 8 12 8 9 12 14 60 12 20 12 24 10 12 12 10 8 30 15 15 15 person-centered plans of care based on remaining capacities of persons with dementia. Recent research in France has extended this work by development of the Montessori Assessment System (MAS). 196 long-term care residents in France with moderate to severe dementia were assessed with the MAS, the MMSE and the Severe Impairment Battery ? short form (SIB-S). In a second study, residents in dementia care units (9 skilled nursing facilities [SNFs] and 7 assisted living residences [ALs] in the U.S.; N�1) exhibiting responsive behaviors which were disruptive and consuming large amounts of staff members? time and energy were put into groups with full-day programming ? Memory in Rhythm (MIR). MIR uses Montessori-based, person-centered approaches to care. Data were collected and compared for the year previous to MIR implementation and for the year after MIR implementation. Results: As shown in Table 1, the MAS has excellent psychometric properties, including test-retest (r � 0.90) and inter-rater reliability (0.95), internal consistency (a � 0.85), as well as good convergent and divergent validity. In addition, residents with dementia generally responded favorably to the assessment experience, while the MAS yielded information which immediately could be translated into person-centered plans of care. In the U.S., multi-residence study, as shown in Table 2, implementation of MIR was associated with the following average reductions: anti-psychotic medication use (SNFs�%; ALs�%), hypnotics (SNFs�%; ALs�%), staff turnover (SNFs�%; ALs�%), wandering (SNFs�%; ALs�%), and agitation (SNFs�%; ALs�%), with increases in weight (SNFs�%; ALs�%), sleeping at night (SNFs�%; ALs�%), and census (SNFs�%; ALs�%), as shown in Table 3. Conclusions: Assessing capacities of persons with dementia, especially those in moderate to advanced stages, is both practical and feasible. Translating this information into programming making use of such Podium Presentations: Sunday, July 16, 2017 information, and targeting residents with highly disruptive responsive behaviors results in desirable outcomes for residents, caregivers, and administrators. F1-01-04 COMPREHENSIVE, INDIVIDUALIZED, PERSON-CENTERED MANAGEMENT PROGRAM IN SUBJECTS TREATED WITH MEMANTINE ENHANCES FUNCTIONING BY 750%, IN COMPARISON WITH MEMANTINE TREATMENT ALONE, IN PERSONS WITH MODERATE-TO-SEVERE AD IN 28-WEEK RANDOMIZED CONTROLLED TRIALS Sunnie Kenowsky1,2, Isabel Monteiro1,2,3, Carol Torossian1,2,3, Sloane Heller1,2, Zabeen Noorani1,2, Yongzhao Shao1,3, Barry Reisberg2,3, 1 New York University School of Medicine, New York, NY, USA; 2New York University Langone Medical Center, New York, NY, USA; 3New York University Alzheimer?s Disease Center, NYU Langone Medical Center, New York, NY, USA. Contact e-mail: sunnie.kenowsky@nyumc.org Background: Memantine was approved as the first treatment for moderate-to-severe AD following a pivotal trial conducted by Reisberg et al. (N Engl J Med., 2003) and other supportive studies. The development of approved treatments that were not curative accentuated the continuing care needs of these AD persons. Therefore we conducted a 28-week randomized controlled trial in which subjects (N�) were randomly assigned to usual community care (UCC) plus memantine treatment, or to a comprehensive, individualized, person-centered management program (CI-PCM) (developed by S.K.), plus P173 memantine treatment (Reisberg, et al., Dement Ger Cog Disord., 2017; 43: 100-117). Significant improvement in the Functional Assessment Staging measure (FAST) (Sclan & Reisberg, Int Psychogeriatr, 1992), was observed at all post-baseline observation periods (p<0.01 at week 28). Herein, we examined the magnitude of functional benefit on the FAST with the CIPCM program in comparison with the magnitude of benefit with memantine treatment alone. Methods: We employed the FAST scoring methodology of the 2003 NEJM trial, termed the FAST disability score (FAST-DS) (see Table 1). We then compared the FAST-DS score magnitude of improvement in the memantine + CI-PCM program, versus the memantine + UCC; with the magnitude of FAST-DS improvement in the 2003 pivotal trial results of memantine versus placebo treatment (see Table 1). Results: The mean difference between the CI-PCM + memantine intervention and the UCC + memantine comparator group FAST-DS score is 3. The mean difference between the memantine treatment versus placebo in the 2003 trial FAST-DS scores is 0.4. Therefore, the CI-PCM program enhanced functioning 7.5 times over memantine treatment alone. Conclusions: A 750% greater improvement in functioning was observed in the CI-PCM program over memantine treatment alone. This enormous effect of the CI-PCM program is consonant with our prior observation of the effects of the CI-PCM program on a global measure of cognition, functioning and behavior, which was approximately 10x that observed in the NEJM memantine trial. We attribute the CI-PCM program success primarily to the participant caregivers learning to memory coach the AD persons to bathe, dress, feed and toilet themselves, to become/maintain urinary and fecal continence, and to speak. Table 1 Functional Assessment Staging Disability Score (FAST-DS)a Comparisons at Week 28: (1) of a Comprehensive, Individualized, Person-Centered Management (CI-PCM) Programb Plus Memantine Treatment versus Usual Community Care (UCC)c Plus Memantine Treatment (Reisberg, et al., Dement Ger Cog Disord., 2017); (2) with the Memantine Treatment versus Placebo Pivotal Trial (Reisberg, et al., N Eng J Med., 2003) CI-PCM + memantine Intervention Groupb CI-PCM study UCC + memantine Comparator Groupc CI-PCM study Memantine Treatment Group, 2003 NEJM Memantine Study Control Group, 2003 NEJM Memantine Study FAST-DS scorea at Baseline (Mean) Observed Casesy Analysis of Change in mean FAST-DS score from Baseline at Week 28 Mean FAST-DS score difference between Treatment Arms at Week 28 4 (n�) 4 (n�) 2.8d (n�6) 2.8d (n�6) -2 (n�) 1 (n�) 0.1d (n�) 0.5d (n�) 3 0.4 a The FAST-DS scores were calculated as: FAST stage (Sclan, S.G., & Reisberg, B., Int Psychogeriatr, 1992) 4 � FAST- DS score of-1, FAST stage 5 � FASTDS score of 0, FAST stage 6a � FAST-DS score of 1, FAST stage 6b � FAST-DS score of 2, FAST stage 6c � FAST-DS score of 3, FAST stage 6d � FAST-DS score of 4, FAST stage 6e � FAST-DS score of 5, FAST stage 7a � FAST-DS score of 6, FAST stage 7b � FAST-DS score of 7, FAST stage 7c � FAST-DS score of 8, FAST stage 7d � FAST-DS score of 9, FAST stage 7e � FAST-DS score of 10 and FAST stage 7f � FAST-DS score of 11; in the same manner as the 2003 pivotal trial (Reisberg, et al., N Eng J Med.). b The CI-PCM program consisted of: a caregiver course in Alzheimer?s care, management assessment, therapeutic residential visits and carer support group meetings (Reisberg, et al., Dement Ger Cog Disord., 2017). c UCC, Usual Community Care. UCC participants had their questions answered and were referred to the local chapter of the Alzheimer?s Association and other community resources when appropriate for day care center and support group programs, caregiver training, care counseling, and safe return/medic alert bracelets by the study Alzheimer?s care specialist (S.K.) or New York University Alzheimer?s Disease Center clinicians and social workers. UCC participants received in total USD 100 compensation upon completion of the week 28 study visit which is unlikely to have had any meaningful clinical effect. The UCC Comparator Group in the CI-PCM study may appear different from the memantine treatment and placebo groups in the 2003 NEJM study on the FAST-DS assessment. However, the sample sizes of the memantine treatment and placebo groups in the 2003 NEJM study were much larger than the sample size of the UCC comparator group in the current CI-PCM study. Therefore, the differences in the UCC CI-PCM study comparator group FAST-DS results are not significantly different from the 2003 memantine treatment or placebo FAST-DS scores. d From Table 2, Reisberg, et al., N Engl J Med., 2003. y Observed cases are the completers of the 28-week CI-PCM study or of the 28-week NEJM trial.
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