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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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slide1

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

slide3

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)
slide4

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

slide5

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

slide6

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

slide7

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

slide8

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
recruitment
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)
study flow march 2011
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

baseline characteristics
Baseline characteristics

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

baseline climat scores
Baseline CLIMAT scores

BL score

Continuing use of ChEI (Cohort 2, cohort 1 continuing) is associated with higher CG but not SB ratings

6 month climat change
6-month CLIMAT change

OPAR INDETERMINATE

OPAR POSITIVE

CH score

subject reported cognitive change
Subject-reported cognitive change

CH score

Naive

Naive

Continuing

Naive

Naive

Continuing

Continuing

Continuing

caregiver reported cognitive change
Caregiver-reported cognitive change

CH score

Naive

Naive

Continuing

Naive

Naive

Continuing

Continuing

Continuing

conclusions
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
slide19

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

slide20

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

slide21

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