The study focuses on Early Alzheimer’s Disease, a condition that causes gradual loss of memory and everyday abilities. The investigational medicine being examined is called TML-6, which is taken as a tablet once daily. The aim of the trial is to determine whether a year of treatment with this drug can slow, stop, or improve the decline in thinking skills and daily function compared with a placebo.
Participants are randomly assigned to receive either the study drug at two possible doses or the placebo, and neither the participants nor the study staff know which treatment is given. Over 52 weeks, participants attend regular clinic visits where safety is checked through physical exams, vital signs, weight measurements, and questionnaires about mood. Cognitive and functional abilities are measured using the clinical dementia rating – sum of boxes, a score that reflects the severity of dementia, and the integrated Alzheimer’s disease rating scale, a test that looks at memory and daily tasks. Blood samples are taken to assess proteins linked to Alzheimer’s, such as p-Tau217 (a form of tau protein), amyloid β-protein Aβ40 and Aβ42 (building blocks of plaque), as well as markers of nerve damage (neurofilament light chain) and brain inflammation (glial fibrillary acidic protein). Brain imaging includes a size‑measuring scan called volumetric magnetic resonance imaging and a special scan that visualizes amyloid plaques known as amyloid positron emission tomography. All data are collected to evaluate whether the medication is safe and whether it helps preserve thinking and daily abilities.
Sweden 
