Condition: Alzheimer Disease · Mild Cognitive Impairment · Sponsor: NeuroTherapia, Inc.
1. Study Overview NeuroTherapia Inc. is conducting a clinical study to explore the safety and effects of a new drug called NTRX- 07. This drug targets people with mild cognitive impairment (MCI) or mild to moderate Alzheimer's disease (AD). The study's primary focus is on safety and how the drug interacts with the body over a short-term period of 28 days. This research is important as it aims to find new ways to manage symptoms and slow the progression of AD. 2. Key Objectives Primary Objective: * To assess the safety and tolerability of NTRX-07 in patients with AD. * Safety and tolerability will be measured by monitoring any side effects or adverse events in participants during and after the treatment period. Secondary Objective: * To study how NTRX-07 is processed by the body, including how it is absorbed, distributed, metabolized, and eliminated. * This includes measuring the drug levels in the blood and cerebrospinal fluid (CSF) over time. 3. Study Design • Type of Study: o A randomized, double-masked, placebo-controlled study. "Randomized" means participants are randomly assigned to receive either the actual drug (NTRX-07) or a placebo (an inactive substance). "Double-masked" indicates that neither the participants nor the researchers know who receives the real drug or the placebo, reducing bias and ensuring objective results. • Participants: * 48 individuals with MCI or mild to moderate AD. • Treatment Groups: * Participants will be …
This description comes directly from the study's public registry record.
Joseph Foss, MD · 4402539266 · joseph.foss@neurotherapia.com
Always discuss trial participation with your own doctor first.
| Neuro Health Centrum s.r.o. | Brno, Czechia | Recruiting |
| Neuropsychiatrie s.r.o. | Prague, Czechia | Recruiting |
| Semmelweis University | Budapest, Hungary | Not Yet Recruiting |
| Semmelweis University | Budapest, Hungary | Not Yet Recruiting |
| Szpital Uniwersytecki W Krakowie | Krakow, Poland | Recruiting |
| Wrocławskie Centrum Alzheimerowskie | Wroclaw, Poland | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07058688