Monoclonal antibody(Normunity)

The emergence of monoclonal antibody (MABs) drugs since the FDA approval of lecanemab has resulted in dramatic changes in the clinical approach and management of early-stage Alzheimer's disease (AD). Challenges with MAB adoption into clinical practice may vary depending on whether the institution is an academic/integrated healthcare organization versus a private neurological practice. We have combined demographic and clinical data from a high-volume East coast private neurology practice and a West coast academic memory clinic at post-MAB adoption. Combined data of N = 165 patient showed the following demographics: mean age 72, 67% female, 92% Caucasian, average MOCA 18/30 with amyloid status confirmed by CSF in 72% of patients. Overall, ARIA rates were 8% for ARIA-E and 7% for ARIA-H, and there were no mortalities over the observation period. Three patients required immediate medical attention due to ARIA radiographic findings associated with clinical symptoms. The private practice enrolled patients with lower average cognitive screening scores than the academic practice, but was more efficient at initiation therapy (mean # of weeks between diagnosis and treatment 97 versus 149 days). The average patient out-of-pocket cost was ($654.38) significantly less than the 20% of the annual drug cost as previously estimated. The findings from two separate clinical environments support the notion that ARIA risk associated with lecanemab is no greater than what was found in the CLARITY-AD trial and that the costs to the patient were less than predicted. This study was limited by the lack of 12 month efficacy data. Additional real-world data relating to the clinical effectiveness of MAB use in clinical practice will be necessary to best determine the risk/benefit ratio of these drugs in community populations.

To meet the growing demand for timely diagnosis in the new era of disease-modifying medications for Alzheimer’s disease (AD), the present study aimed to reduce clinic wait times by developing and refining an abbreviated neuropsychological battery to assess individuals with a suspected amnestic process (i.e., Early-Stage AD Pathway).

Early-Stage AD Pathway patients were referred by an internal neurology provider who determined that the patient had: (1) an amnestic clinical presentation, (2) a normal neurological examination, and (3) a Montreal Cognitive Assessment total score between 18 and 25. These patients were scheduled for a 2-h neuropsychological evaluation, including a brief clinical interview and an abbreviated testing battery. We evaluated n = 19 patients in the Early-Stage AD Pathway and compared them to 114 older adults referred via traditional clinic procedures (i.e., General Clinic).

Most individuals evaluated via the Early-Stage AD Pathway were diagnosed with mild cognitive impairment (MCI; 68.4%) or mild dementia (21.1%) through the neuropsychological evaluation. Rate of diagnosis of MCI/dementia was comparable between groups. The average number of days between initial referral and completion of the neuropsychological evaluation was significantly lower (Mdiff = 145.8 days, U = 1867.500, p < 0.001) for the Early-Stage AD Pathway group than for the General Clinic group, as the former could be scheduled more flexibly.

Implementing an abbreviated neuropsychological assessment process significantly reduced the time between referral and evaluation to identify individuals who may be eligible for emerging pharmacological treatments for AD and/or non-pharmacological interventions in a timely manner.