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The ADTI CLIMAT ( Clinical Meaningfulness in Alzheimer Disease ) Study

The ADTI CLIMAT ( Clinical Meaningfulness in Alzheimer Disease ) Study. Claudia Jacova Assistant Professor Division of Neurology claudija@interchange.ubc.ca. Presented at the 26 th International Conference of Alzheimer’s Disease International, Toronto, March 27, 2011.

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The ADTI CLIMAT ( Clinical Meaningfulness in Alzheimer Disease ) Study

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  1. The ADTI CLIMAT (ClinicalMeaningfulness in Alzheimer Disease) Study Claudia Jacova Assistant Professor Division of Neurology claudija@interchange.ubc.ca Presented at the 26th International Conference of Alzheimer’s Disease International, Toronto, March 27, 2011

  2. No conflicts of interest to disclose

  3. ADTI CLIMAT study team • PI: Claudia Jacova (UBC) • Co-PI: Philip Lee (UBC & St. Paul’s) • Co-Is: G-Y Robin Hsiung (UBC), Marilyn Bater (Royal Jubilee), Pamela Thornton (Peace Arch) • Project Manager: Penny Slack (UBC)

  4. CLIMAT Scale • Novel instrument for the measurement of clinically meaningful change • The guiding hypotheses: • Two distinct dimensions matter in AD symptom assessment: Severity of impairment,and severity of impact • Impact is a basis for weighting change. © Jacova, Feldman, Schulzer, Money, UBC Invention Disclosure 2007

  5. CLIMAT Example of change: + 2 units Gain Loss 25 20 15 10 Impact/Impairment ratio 5 Weighted change 0 0.1 0.5 1 2 10 -5 -10 Less impactful More impactful -15 -20 -25

  6. Description • Clinician-rated scale • Separate subject and caregiver interviews • 17 items assessed within: • social function, everyday function, cognition, behaviour • Impairment and impact assessed at baseline; impairment tracked over time Interview notes entered here © Jacova, Feldman, Schulzer, Money, UBC Invention Disclosure 2007

  7. CLIMAT Ratings Comparators CDR Boxes CLIMAT IMPAIRMENT QOL-AD [Sub / CG] CLIMAT IMPACT Evidence supports validity for subject-reported impairment and impact, and for caregiver-reported impairment

  8. ADTI CLIMAT study • Aim: Refine our understanding of clinically meaningful treatment response to cholinesterase inhibitors • Key research questions: • Characterize positive treatment response • Resolve indeterminate treatment response • Track longer-term response trajectories • Derive clinical probes that can guide treatment decisions

  9. Renewal Special Authority Form OPAR

  10. Recruitment • Goal: • 250 subject /caregiver dyads • Subjects naive or non-naive to ChEI • Newly enrolled in ADTI • Challenges: • Slow start: small number of referrals, ethics approval from different health authorities, no research infrastructure at non-UBC sites • Current: • Revised inclusion criteria with recruitment of any ADTI enrolee • 70 subject / caregiver dyads with subject newly enrolled in ADTI at start of study (Cohort 1) • 20 subject / caregiver dyads with subject already enrolled in ADTI (Cohort 2)

  11. Study flow March 2011 Recruitment: 90 SB/CG dyads 82 SB/CG dyads BL CLIMAT & ADTI assessment 29 SB/CG dyads 6-M CLIMAT & ADTI assessment 15 SB/CG dyads 12-M CLIMAT & ADTI assessment 3 SB/CG dyads 18-M CLIMAT & ADTI assessment Loss to f/u: 3 SB/CG dyads: 2 unwilling, 1 unable to attend interview Loss to f/u: 1 SB/CG dyad: no longer SA eligible Loss to f/u: 2 SB/CG dyads: stopped ChEI treatment despite SA eligibility

  12. Baseline characteristics * p<.05 between naive and continuing in Cohort 1; ** p<.05 between Cohort 1 and Cohort 2

  13. Baseline CLIMAT scores BL score Continuing use of ChEI (Cohort 2, cohort 1 continuing) is associated with higher CG but not SB ratings

  14. 6-month CLIMAT change OPAR INDETERMINATE OPAR POSITIVE CH score

  15. Boxplots of impact/impairment ratios for individual items Social Functional Cognitive Behavioural

  16. Subject-reported cognitive change CH score Naive Naive Continuing Naive Naive Continuing Continuing Continuing

  17. Caregiver-reported cognitive change CH score Naive Naive Continuing Naive Naive Continuing Continuing Continuing

  18. Conclusions • Subjects and caregivers’ perceptions of symptoms inform clinically meaningful change • Subjects may have a more positive perception of their symptoms and symptom changes than caregivers • The assessment of the subjective dimension of impact may help resolve clinically indeterminate response

  19. UBC Alzheimer Research Unit Non-UBC Sites Penny Slack William Wang Michele Assaly Phoenix Bouchard Alice Fok Bonnie Leung Jonathan Money Benita Mudge Joanne Ng Pheth Sengdy B. Lynn Beattie GY Robin Hsiung Philip Lee Dean Foti Howard Feldman Ian R. Mackenzie Sunsern Limsoontarakul Peace Arch Hospital, White Rock, BC Pamela Thornton David Gayton Mary-Grace Parr Heather Esau Heidi Cumberworth Donna Horahan Royal Jubilee Hospital, Victoria, BC Marilyn Bater Marilyn Malone Michael Cooper Laurie Robson Ralph Fisher & Alzheimer Society of BC Professorship in Alzheimer’s Research Endowment Fund

  20. CAREGIVER SUBJECT .57* CDR BOXES CDR BOXES .37* CLIMAT IMPAIRMENT CLIMAT IMPAIRMENT .09 -.01 -.22 -.24 QOL-AD [CG] QOL-AD [SUB] CLIMAT IMPACT CLIMAT IMPACT -.23 -.37* Convergent & discriminant validity for impairment and impact Convergent & discriminant validity for impairment Jacova et al. Alzheimer’s & Dementia 2009

  21. Treatment response in AD • Only ~half of AD trials to date have addressed the clinical meaningfulness of their results • Yet, clinical meaningfulness and its measurement are pivotal in dementia where treatments have no normative outcomes Molnar et al. JAGS 2009

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