Testing Atomoxetine, Metformin, or Placebo Added to Standard Care for 18-Month Treatment of Alzheimers Disease Symptoms

What this Trial Is About

Researchers are evaluating treatments for symptomatic Alzheimers Disease in a Phase 3 trial designed to measure sustained clinical response over 18 months. The study uses a multi-arm, multi-stage adaptive design to compare standard care plus placebo, atomoxetine, or metformin in participants representative of the UK Alzheimers population. The trial aims to assess changes in cognitive function and daily living activities, with additional focus on symptoms, quality of life, caregiver impact, safety, and economic outcomes. Participants are randomly assigned to one of three groups receiving standard care plus either a placebo capsule, oral atomoxetine up to 100 mg daily, or oral metformin up to 2000 mg daily. The trial includes interim analyses at several stages to decide if any treatment arm should be stopped early due to lack of activity. Blood biomarkers and MRI scans are also collected to explore disease progression and treatment effects. During the study, participants will undergo assessments including cognitive tests, daily living activity questionnaires, neuropsychiatric evaluations, quality of life surveys, and caregiver burden measures at baseline and throughout 18 months. Safety is monitored by tracking adverse events and health resource use. MRI imaging and blood samples are used for exploratory analyses. Participants are expected to adhere to treatment and assessment schedules, with regular visits for evaluation and monitoring throughout the trial period.

An Evaluation of Treatments for Sustained Clinical Response (18 Months) in Symptomatic Alzheimer's Disease