Adding Delayed Recall to the Alzheimer Disease Assessment Scale is Useful in Studies of Mild Cognitive Impairment but Not Alzheimer Disease

Mary Sano, Rema Raman, Jennifer Emond, Ronald G. Thomas, Ronald Carl Petersen, Lon S. Schneider, Paul S. Aisen

Research output: Contribution to journalArticle

22 Citations (Scopus)

Abstract

Objective: To determine if the addition of delayed recall (DR) assessment adds sensitivity to the cognitive subscale of the Alzheimer Disease Assessment Scale (ADAS-cog) in clinical trials in mild cognitive impairment (MCI) and Alzheimer Disease (AD). Background: Memory, particularly DR, is the most sensitive test for early detection of AD and MCI. However, it is not clear that assessment of DR adds benefit for measuring change over time after a diagnosis is made or in clinical trials. The ADAS-cog is the most commonly used tool to assess treatment efficacy in AD clinical trials. In an attempt to improve sensitivity to change, assessment of DR after the 3-trial, 10-word list was added to the standard 11-item ADAS-cog. We examined the added value of the DR in participants with MCI and AD followed for at least 1 year. Design/Methods: Data from 111 subjects with AD and 259 subjects with MCI who were randomly assigned to the placebo arm of 2 clinical trials were included. Participants with AD had Mini-Mental State Examination scores of 13 to 27 and those with MCI had 24 to 30. We calculated the ADAS-cog11 score based on the original 11 items (range: best to worse, 0 to 70), the DR item score (range: 0 to 10 words not recalled), and the ADAS-cog12 (range: 0 to 80). We assessed the rate of missing items for DR over time, the change scores, the association between scores and baseline performance, and used longitudinal mixed effects regression models to examine the rate of change. Results: At baseline AD subjects were near floor on DR (8.93±1.6 SD) and showed little change over 1 year (0.12±1.34); the MCI subjects baseline DR was 6.2±2.2 with 1-year change of 0.20±1.7. We compared standardized change (change/SD) for ADAS-cog11, and 12 in MCI and found a 10% improvement with ADAS-cog12; there was no improvement in the AD group. In a subset of MCI and AD cases with matching Mini-Mental State Examination (23 to 27), the ADAS-cog12 provided an 18% improvement in standardized change in MCI subjects, with no benefit in the AD cohort, primarily owing to increased variance. Conclusions/Relevance: The addition of DR to the ADAS-cog score increased the ability to detect change in subjects with MCI over 1 year compared with the ADAS-cog11 but increased the variance in subjects with AD, even in those with mild impairment These findings speak to the need to tailor outcome measures to the specific study population and diagnosis for maximal efficiency and economy when conducting clinical trials.

Original languageEnglish (US)
Pages (from-to)122-127
Number of pages6
JournalAlzheimer Disease and Associated Disorders
Volume25
Issue number2
DOIs
StatePublished - Apr 2011
Externally publishedYes

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Alzheimer Disease
Clinical Trials
Cognitive Dysfunction
Repression (Psychology)
Aptitude
Early Diagnosis
Placebos
Outcome Assessment (Health Care)
Efficiency

Keywords

  • Alzheimer disease
  • Alzheimer Disease Assessment Scale
  • clinical trial outcomes
  • delayed recall
  • mild cognitive impairment

ASJC Scopus subject areas

  • Geriatrics and Gerontology
  • Psychiatry and Mental health
  • Gerontology
  • Clinical Psychology

Cite this

Adding Delayed Recall to the Alzheimer Disease Assessment Scale is Useful in Studies of Mild Cognitive Impairment but Not Alzheimer Disease. / Sano, Mary; Raman, Rema; Emond, Jennifer; Thomas, Ronald G.; Petersen, Ronald Carl; Schneider, Lon S.; Aisen, Paul S.

In: Alzheimer Disease and Associated Disorders, Vol. 25, No. 2, 04.2011, p. 122-127.

Research output: Contribution to journalArticle

Sano, Mary ; Raman, Rema ; Emond, Jennifer ; Thomas, Ronald G. ; Petersen, Ronald Carl ; Schneider, Lon S. ; Aisen, Paul S. / Adding Delayed Recall to the Alzheimer Disease Assessment Scale is Useful in Studies of Mild Cognitive Impairment but Not Alzheimer Disease. In: Alzheimer Disease and Associated Disorders. 2011 ; Vol. 25, No. 2. pp. 122-127.
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AU - Raman, Rema

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AU - Thomas, Ronald G.

AU - Petersen, Ronald Carl

AU - Schneider, Lon S.

AU - Aisen, Paul S.

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N2 - Objective: To determine if the addition of delayed recall (DR) assessment adds sensitivity to the cognitive subscale of the Alzheimer Disease Assessment Scale (ADAS-cog) in clinical trials in mild cognitive impairment (MCI) and Alzheimer Disease (AD). Background: Memory, particularly DR, is the most sensitive test for early detection of AD and MCI. However, it is not clear that assessment of DR adds benefit for measuring change over time after a diagnosis is made or in clinical trials. The ADAS-cog is the most commonly used tool to assess treatment efficacy in AD clinical trials. In an attempt to improve sensitivity to change, assessment of DR after the 3-trial, 10-word list was added to the standard 11-item ADAS-cog. We examined the added value of the DR in participants with MCI and AD followed for at least 1 year. Design/Methods: Data from 111 subjects with AD and 259 subjects with MCI who were randomly assigned to the placebo arm of 2 clinical trials were included. Participants with AD had Mini-Mental State Examination scores of 13 to 27 and those with MCI had 24 to 30. We calculated the ADAS-cog11 score based on the original 11 items (range: best to worse, 0 to 70), the DR item score (range: 0 to 10 words not recalled), and the ADAS-cog12 (range: 0 to 80). We assessed the rate of missing items for DR over time, the change scores, the association between scores and baseline performance, and used longitudinal mixed effects regression models to examine the rate of change. Results: At baseline AD subjects were near floor on DR (8.93±1.6 SD) and showed little change over 1 year (0.12±1.34); the MCI subjects baseline DR was 6.2±2.2 with 1-year change of 0.20±1.7. We compared standardized change (change/SD) for ADAS-cog11, and 12 in MCI and found a 10% improvement with ADAS-cog12; there was no improvement in the AD group. In a subset of MCI and AD cases with matching Mini-Mental State Examination (23 to 27), the ADAS-cog12 provided an 18% improvement in standardized change in MCI subjects, with no benefit in the AD cohort, primarily owing to increased variance. Conclusions/Relevance: The addition of DR to the ADAS-cog score increased the ability to detect change in subjects with MCI over 1 year compared with the ADAS-cog11 but increased the variance in subjects with AD, even in those with mild impairment These findings speak to the need to tailor outcome measures to the specific study population and diagnosis for maximal efficiency and economy when conducting clinical trials.

AB - Objective: To determine if the addition of delayed recall (DR) assessment adds sensitivity to the cognitive subscale of the Alzheimer Disease Assessment Scale (ADAS-cog) in clinical trials in mild cognitive impairment (MCI) and Alzheimer Disease (AD). Background: Memory, particularly DR, is the most sensitive test for early detection of AD and MCI. However, it is not clear that assessment of DR adds benefit for measuring change over time after a diagnosis is made or in clinical trials. The ADAS-cog is the most commonly used tool to assess treatment efficacy in AD clinical trials. In an attempt to improve sensitivity to change, assessment of DR after the 3-trial, 10-word list was added to the standard 11-item ADAS-cog. We examined the added value of the DR in participants with MCI and AD followed for at least 1 year. Design/Methods: Data from 111 subjects with AD and 259 subjects with MCI who were randomly assigned to the placebo arm of 2 clinical trials were included. Participants with AD had Mini-Mental State Examination scores of 13 to 27 and those with MCI had 24 to 30. We calculated the ADAS-cog11 score based on the original 11 items (range: best to worse, 0 to 70), the DR item score (range: 0 to 10 words not recalled), and the ADAS-cog12 (range: 0 to 80). We assessed the rate of missing items for DR over time, the change scores, the association between scores and baseline performance, and used longitudinal mixed effects regression models to examine the rate of change. Results: At baseline AD subjects were near floor on DR (8.93±1.6 SD) and showed little change over 1 year (0.12±1.34); the MCI subjects baseline DR was 6.2±2.2 with 1-year change of 0.20±1.7. We compared standardized change (change/SD) for ADAS-cog11, and 12 in MCI and found a 10% improvement with ADAS-cog12; there was no improvement in the AD group. In a subset of MCI and AD cases with matching Mini-Mental State Examination (23 to 27), the ADAS-cog12 provided an 18% improvement in standardized change in MCI subjects, with no benefit in the AD cohort, primarily owing to increased variance. Conclusions/Relevance: The addition of DR to the ADAS-cog score increased the ability to detect change in subjects with MCI over 1 year compared with the ADAS-cog11 but increased the variance in subjects with AD, even in those with mild impairment These findings speak to the need to tailor outcome measures to the specific study population and diagnosis for maximal efficiency and economy when conducting clinical trials.

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