This study is testing a new investigational drug called 8M2D to learn whether it is safe and well-tolerated in humans. 8M2D has not previously been given to people. Hypothesis: Researchers believe that 8M2D can be administered safely to healthy adults and to people with early Alzheimer's disease, and that it may reduce levels of amyloid beta. Amyloid beta is a protein that builds up in the brains of people with Alzheimer's disease and is thought to contribute to its progression. The study will be conducted in three parts. In the first two parts, healthy volunteers will receive either a single dose or multiple doses of 8M2D so researchers can understand how the drug moves through the body and whether it causes any side effects. In the third part, a small group of people with early Alzheimer's disease will receive multiple doses so researchers can also begin to assess whether the drug has any effect on amyloid beta levels. Doses will be increased gradually and carefully. An independent safety board will review safety information before any dose increase is allowed. The information gathered in this study will be used to identify the appropriate dose of 8M2D and to help design future studies in people with Alzheimer's disease.
Age range
18 Years – 80 Years
Sex
ALL
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Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Number of participants reporting treatment-emergent adverse events
Timeframe: Baseline to Day 44
Number of participants reporting treatment-emergent adverse events that require discontinuation of therapy due to intolerable side effects
Timeframe: Baseline to Day 14
Number of participants reporting injection site reactions
Timeframe: Baseline to Day 22
Number of participants demonstrating abnormal laboratory findings
Timeframe: Baseline to Day 14
Number of participants demonstrating abnormal vital signs
Timeframe: Baseline to Day 22
Number of participants demonstrating abnormal vital electrocardiogram (ECG) parameters
Timeframe: Baseline to Day 15
Number of participants demonstrating adverse changes in physical and/or neurologic examinations
Timeframe: Baseline to Day 22
Number of participants reporting changes in Columbia-Suicide Severity Rating Scale (C-SSRS) from baseline
Timeframe: Baseline to Day 22
Maximum observed concentration (Cmax) of 8M2D
Timeframe: Baseline to Day 14
Time to maximum observed concentration (tmax) of 8M2D
Timeframe: Baseline to Day 14
Area under the concentration-time curve from time 0 to the last quantifiable concentration (AUC-last) of 8M2D
Timeframe: Baseline to Day 14
Terminal phase half-life (t1/2)
Timeframe: Baseline to Day 14
Area under the concentration-time curve from time 0 to infinity (AUC-inf)
Timeframe: Baseline to Day 14
Assessment of changes from baseline after 14 days of dosing in plasma and CSF biomarkers of AD [such as Aβ42, Aβ40, p-tau217, and np-tau217
Timeframe: Baseline to Day 14