A Phase 1, First-in-Human Study to Evaluate the Safety and Pharmacokinetics of RO7812653 in Patients with Early Symptomatic Alzheimer’s Disease

The primary objective of this first-in-human study is to evaluate the safety and tolerability of RO7812653 in individuals diagnosed with early symptomatic Alzheimer’s disease, which includes patients with mild cognitive impairment or probable Alzheimer’s disease dementia. Assessing these parameters is essential for determining the initial clinical profile of the investigational product before further clinical development. No secondary objectives were identified.

The study involves a total of 70 patients diagnosed with early symptomatic Alzheimer’s disease, which encompasses mild cognitive impairment due to the condition or probable Alzheimer’s disease dementia. The study population includes both male and female participants. Based on the provided age range codes, the subjects belong to specific age categories. The sponsor did not provide additional information regarding lifestyle considerations or the selection process.

This Phase 1, first-in-human study evaluates the safety and pharmacology of RO7812653 in individuals diagnosed with early symptomatic Alzheimer’s disease, which includes mild cognitive impairment due to Alzheimer's or probable Alzheimer’s dementia. The clinical trial follows a specific sequence of study visits beginning with a screening visit to assess eligibility. Subsequent follow-up visits are conducted to monitor physiological responses and safety parameters, concluding with an end-of-study visit. The total duration of the research period is estimated to span from December 2025 to September 2029. Participant involvement may be subject to early termination based on predefined safety criteria or protocol deviations.

Efficacy assessment for participants with early symptomatic Alzheimer’s disease will be conducted within the framework of this clinical trial. The evaluation focuses on individuals diagnosed with mild cognitive impairment due to Alzheimer's or probable Alzheimer's dementia.