ADCS-CGIC SCALE PDF

Schneider, MD, Christopher M. Ferris, PhD, John C. We assessed feasibility for its use by determining whether or not: 1 it distinguished a medication effect at 6- and months, 2 baseline demographic or clinical characteristics predicted change, 3 there was an association between MCI-CGIC and change in other clinical measures in order to evaluate external or concurrent validity. Methods We used a generalized estimating equations approach for ordinal outcome data to test the effects of treatment, baseline characteristics and change in clinical measures on the MCI-CGIC over 12 months, and ordinal logistic regression to assess the association between MCI-CGIC and change in clinical measures at 6 months and 12 months. Variables at screening or baseline that were associated with worse CGIC scores over 6 and 12 months included white race, greater years of education, worse depression, dementia severity rating, cognitive, and daily activities scores, and lower memory domain scores on a neuropsychological battery.

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Schneider, MD, Christopher M. Ferris, PhD, John C. We assessed feasibility for its use by determining whether or not: 1 it distinguished a medication effect at 6- and months, 2 baseline demographic or clinical characteristics predicted change, 3 there was an association between MCI-CGIC and change in other clinical measures in order to evaluate external or concurrent validity.

Methods We used a generalized estimating equations approach for ordinal outcome data to test the effects of treatment, baseline characteristics and change in clinical measures on the MCI-CGIC over 12 months, and ordinal logistic regression to assess the association between MCI-CGIC and change in clinical measures at 6 months and 12 months.

Variables at screening or baseline that were associated with worse CGIC scores over 6 and 12 months included white race, greater years of education, worse depression, dementia severity rating, cognitive, and daily activities scores, and lower memory domain scores on a neuropsychological battery.

The effect size of the donepezil-placebo difference was similar to that of other outcomes at 12 months. Overall global change or severity scales ratings, or alternatively, activities of daily living scales, are required co-primary outcomes in regulatory or registration trials for drugs for dementia 2.

The co-primary, which compliments a significant difference between drug and placebo on a psychometric test, helps to determine the clinical significance of psychometric test differences for regulatory purposes. It is a severity scale that assesses the current state of a patient without reference to a prior state and does not rate change over time.

The ADCS MCI-CGIC was designed to provide a means to assess global change in an MCI clinical trial by providing a semi-structured format to allow clinicians to gather necessary clinical information from both the subject and informant in order to allow for an overall impression of clinical change.

The goals of this investigation were to assess the feasibility of the use of this modified ADCS-CGIC in MCI clinical trials by assessing whether or not the CGIC distinguished a medication effect, whether or not baseline demographic or clinical characteristics predicted change, and whether or not there was an association between MCI-CGIC change and change in other clinical measures, to assess external or concurrent validity.

Briefly patients with MCI were randomized to donepezil, vitamin E, or placebo, and completed baseline assessments and were followed for up to three years 5. The primary outcome of the trial was time to the development of possible or probable AD. Cognitive-domain scores for memory the ADAS-cog immediate and delayed word-recall scores and the NYU immediate and delayed paragraph-recall scores , executive function the digits-backward test, Symbol Digit Modalities Test, and number-cancellation test , language the Boston Naming Test and category-fluency test , and visuospatial skills the clock-drawing test were calculated in addition to an overall composite cognitive-function score.

These domain and composite scores were calculated as the weighted sum of the individual standardized test scores standardized by dividing each score by the standard deviation of the baseline scores. Weights were calculated as the reciprocal of the sum of the correlation coefficients between the tests in each domain at baseline. Maze tracing was not used in the domain score calculations. The measures were administered at 6-month intervals over three years except that the ADAS-cog and NTB were administered at 3 months as well; and the CADQoL was administered at 3 months and then at month intervals from baseline.

Written informed consent was obtained from all participants and study partners. Significant effects for vitamin E were observed on the NTB overall score at 6 months none of these corrected for multiple comparisons 5. The CGIC rating is made on a 7-point Likert-type scale where change from baseline is rated as marked improvement 1 , moderate improvement 2 , minimal improvement 3 , no change 4 , minimal worsening 5 , moderate worsening 6 , marked worsening 7.

At baseline, the clinician interviews the subject and informant about baseline status for later reference. At baseline only, clinical information about the subject may be used, including medical history, physical and neurological examination, and other ratings done at screening. A third column provides space for notes. There are separate spaces for notes taken from the subject and informant interviews.

At interval assessments, the subject is interviewed first, followed by the informant. Statistical Analysis To assess the rate of change in MCI-CGIC over 12 months and its association with each of the covariates of interest, the longitudinal analysis was done using a generalized estimating equations GEE approach, which accounts for within-subject correlation. Because very few change scores were at the extreme ratings of marked worsening, moderate worsening, marked improvement, or moderate improvement, we evaluated the rate of change of MCI-CGIC using two models.

The GEE method is suitable for the longitudinal analysis of both binary and ordinal outcomes. These models estimate odds ratios that indicate the relationship between the response variable and the covariates.

GEE models for binary data assuming a logistic function and ordinal data using a proportional odds model were used for the two models. The proportional odds model is very similar to the GEE model for binary data, with the difference being that a covariate effect leads to an increase in the likelihood of the patient being in any subsequent higher MCI-CGIC category.

To determine if the change in MCI-CGIC over 12 months differed between patients randomized to donepezil, vitamin E, or placebo, a GEE model for ordinal data was fit to the data to account for the clustering due to the repeated observations within a patient. The dependent variable in the model was the MCI-CGIC scores over time 6 months, 12 months and the independent variables included a treatment factor placebo, vitamin E and donepezil , a time factor 6 and 12 months , and the treatment by time interaction.

The dependent variable in the model was the MCI-CGIC scores over 12 months and the independent variables included change in secondary measures as a time varying covariate , a time factor 6 and 12 months , and the secondary measure by time interaction. Missing data at 12 months was imputed using last observation carried forward LOCF.

All models were adjusted for three pre-specified covariates, age, ApoE4 status and screening MMSE, similar to the model used in the primary MCI report 5 along with any additional observed confounders. No adjustments for multiple comparisons were made given the exploratory nature of the hypotheses. Possible co-linearity between baseline MMSE and other baseline predictors were assessed using Spearman correlation coefficients.

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Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC or CIBIC+)

Alzheimer Dis Assoc Disord. There is a need for proxy-administered outcome measures. This involved comparison of data acquisition from both home and clinic and the use of both informant-ratings and self-ratings. Important outcomes included clinical global impressions of change CGIC as indicators of clinically meaningful change. Such ratings provide verification that the effects of a medication as measured on rating scales are readily observable and clinically meaningful. One objective was to develop self-rated and study partner-rated CGICs optimized for nondemented elderly or people with very early Alzheimer disease. An important consideration was whether global assessments are specific and sensitive measures of change during a prevention trial.

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CGIC or ADCS-CGIC:

Daiktilar We used a generalized estimating equations approach for ordinal outcome data to test the effects of treatment, baseline characteristics, and change in clinical measures on the MCI-CGIC over 12 months, and ordinal logistic regression to assess the association between MCI-CGIC and change in clinical measures at 6 months and 12 months. The difference in magnitude of the MCI-CGIC between donepezil or vitamin E treatment compared to placebo was similar to other secondary clinical outcomes — both significant and not — in a trial in which the medications did not show overall advantages compared to placebo. Hypothesis 1, drug v. Insel report that they have no relationships to disclose.

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