Clinical Trial Issues

Various clinical instruments have been used in the diagnosis of AD and can be used to monitor drug efficacy. These include the AD Assessment Scale (ADAS), noncognitive versus cognitive (cog), the Blessed Dementia Scale (BDS), the Blessed Information Memory Concentration (BIMC), the Behavior Rating Scale for Dementia (BRSD), the Clinical Dementia Rating (six categories; CDR), the Clinician's Interview-based Impression of Change (CIBIC), the Sum of Boxes (Global CDR, CDR-SB), the Dementia Rating Scale (DRS), the Extended Scale for Dementia (ESD), Global Deterioration Scale (GDS), the Mini-Mental State Examination (MMSE), the Progressive Deterioration Scale (PDS), and the Severe Impairment Battery (SIB).27 Each scale measures both cognitive ability and activity of daily living but they are difficult to compare as their absolute ranges are very different, making comparison of results across clinical trials using different scales difficult. Thus, the only basis to compare data is on the percentage change from a baseline value. The ADAS-cog, CIBIC, and MMSE are most frequently used as primary endpoints in AD clinical trials. An unusual feature of AD clinical trials is that informed consent is typically consent given by the caregiver and not by the patient.

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