A Multicenter, Randomized, Double-masked, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NTRX-07 in Subjects With Mild Cognitive Impairment or Mild to Moderate Alzheimer's Disease

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 split into two groups: 24 will receive NTRX-07, and 24 will receive a placebo.

• Duration:

• The study will last up to 7-10 weeks for each participant, including a 28-day period during which they take the drug or placebo daily.

4. Study Procedures

• Screening Period:

• Before starting the treatment, participants will undergo a screening period of up to 45 days. During this time, they will have tests to confirm their eligibility, including physical exams, blood tests, cognitive assessments, and brain imaging (MRI).

• Treatment Period (28 days):

• Participants will take the study drug or placebo daily for 28 days. During this period, they will visit the study center for evaluations, including safety checks, cognitive tests, blood and CSF sampling, and EEG tests (to measure brain activity).

• Follow-Up:

• After the treatment period, participants will have a follow-up visit 7 days later for final safety assessments.

5. Safety Monitoring and Assessments

• The study's primary focus is on safety. Researchers will monitor participants closely for any adverse events, such as side effects, throughout the study.
• Safety assessments will include monitoring vital signs (blood pressure, heart rate, temperature), conducting laboratory tests (blood and urine analysis), performing physical examinations, and using electrocardiograms (ECGs) to monitor heart health.

6. Exploratory Assessments

• Although this study primarily focuses on safety, researchers will also conduct exploratory assessments to observe any potential positive effects of NTRX-07 on brain function and symptoms of AD. These will include:

o Cognitive Testing:

• Standard tests like the AD Assessment Scale-Cognitive Subscale (ADAS-cog) and the Mini-Mental State Examination (MMSE) will be used to evaluate any changes in cognitive function.

o Brain Imaging:

• MRI scans will help assess changes in brain structure and inflammation.

o Biomarkers:

• Blood and CSF samples will be analyzed for specific biomarkers related to inflammation, brain health, and AD progression.

7. Eligibility Criteria

• Inclusion Criteria:

• Individuals aged 65-88 with a confirmed diagnosis of MCI or mild to moderate AD.

• Must have a caregiver who can assist with the study requirements.

• Must be able to undergo specific procedures like MRI scans and CSF sampling.

• Exclusion Criteria:

• Individuals with other significant health conditions or history of neurological disorders other than AD.

• Those currently participating in another clinical trial or have certain medication restrictions.

8. Importance of the Study AD is a progressive condition that affects memory, thinking, and behavior. Current treatments only manage symptoms temporarily, and there is an need for new therapies. NTRX-07 is a novel drug that has shown promise in animal studies, potentially reducing brain inflammation, clearing harmful proteins, and improving memory and learning. This study is an essential step toward understanding if NTRX-07 can offer a safe and effective treatment option for people with AD.
9. Summary This clinical trial is designed to test the safety and processing of a new drug, NTRX-07, in people with MCI or mild to moderate AD. Participants will be carefully monitored for any side effects while researchers also gather data on the drug's impact on brain function. If successful, this study could lead to more advanced trials and, ultimately, a new treatment option for those affected by AD.