The psychometric evaluation of the ADCS-ADL-MCI was undertaken using data from the ADCS ADC-008 trial, a 36-month, multicenter, randomized, double-blind, parallel-group, placebo-controlled study in subjects with amnestic MCI [19 (link)]. All subjects were aged 55–91 years (inclusive) and met criteria for amnestic MCI of a presumably degenerative nature (insidious onset, gradual progression) defined as: 1) subjective memory complaint corroborated by an informant; 2) general cognition and functional ability sufficiently preserved so that a diagnosis of AD dementia or non-AD dementia could not be made; 3) abnormal memory function defined as scoring below the education-adjusted normative cutoff value on one paragraph from the Wechsler Memory Scale-Revised Logical Memory II subtest, 4) a global Clinical Dementia Rating score of 0.5, and 5) a Mini-Mental State Examination (MMSE) score ≥ 24 [20 (link)]. Clinical diagnosis was assigned absent biomarker evidence of disease pathology. Eligible subjects who completed the screening visit and gave informed consent were randomly assigned to one of the following three treatment groups in a double-blind fashion: Placebo plus a multivitamin daily (n = 259); Vitamin E (2,000 IU) plus a multivitamin daily (n = 257); or donepezil (10 mg) plus a multivitamin daily (n = 253). The primary outcome was the development of possible or probable AD dementia.
The science of evaluating an instrument’s measurement properties does not consider the biological mechanism of the underlying disease process and is agnostic as to the reasons why patients are in the evaluated disease state. As such, disease experiences as viewed through clinical measures and patient-reported outcomes resulting from treatment are considered equally usable to non-treated natural history patients (i.e., the instrument is applicable across the disease continuum). The psychometric evaluation of the ADCS-ADL-MCI was thus performed on all randomized subjects in the ADC-008 dataset for whom the ADCS-ADL-MCI was measured (N = 769). Further details of this trial are reported elsewhere [19 (link)]. All methods were carried out in accordance with relevant guidelines and regulations under IRB #981135.
The science of evaluating an instrument’s measurement properties does not consider the biological mechanism of the underlying disease process and is agnostic as to the reasons why patients are in the evaluated disease state. As such, disease experiences as viewed through clinical measures and patient-reported outcomes resulting from treatment are considered equally usable to non-treated natural history patients (i.e., the instrument is applicable across the disease continuum). The psychometric evaluation of the ADCS-ADL-MCI was thus performed on all randomized subjects in the ADC-008 dataset for whom the ADCS-ADL-MCI was measured (N = 769). Further details of this trial are reported elsewhere [19 (link)]. All methods were carried out in accordance with relevant guidelines and regulations under IRB #981135.
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