Actively Recruiting
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
Led by NeuroTherapia, Inc. · Updated on 2025-07-10
48
Participants Needed
6
Research Sites
25 weeks
Total Duration
On this page
Sponsors
N
NeuroTherapia, Inc.
Lead Sponsor
C
Cruint Global Consulting Pte Ltd
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effects of a new drug called NTRX-07 in people aged 65 to 80 with mild cognitive impairment or mild to moderate Alzheimer's disease. This phase 2, randomized, double-masked, placebo-controlled study aims to understand how the drug interacts with the body over a 28-day treatment period, focusing mainly on safety and tolerability. The study is important as it explores new options to manage symptoms and potentially slow Alzheimer's progression. Participants will be randomly assigned to one of two groups: one receiving NTRX-07 orally as two 45 mg tablets once daily, and the other receiving matching placebo tablets daily for 28 days. Before treatment, there is a screening period of up to 45 days to confirm eligibility, including physical exams, cognitive assessments, MRI brain scans, and blood tests. After the treatment period, participants have a follow-up visit 7 days later for final safety checks. During the study, participants will have regular evaluations including safety monitoring of vital signs, physical exams, lab tests, ECGs, and cognitive testing using tools like ADAS-cog and MMSE. Blood and cerebrospinal fluid samples will be collected to measure drug levels and biomarkers related to Alzheimer's disease. Brain activity will be assessed with EEG, and MRI scans will evaluate brain structure changes. The total involvement for each participant lasts about 7 to 10 weeks, including screening, treatment, and follow-up.
CONDITIONS
Brief Title
A Study of NTRX-07 in Participants With Alzheimer's Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must be 65-80 years of age inclusive at the time of consent.
- Diagnosis of mild cognitive impairment or mild to moderate Alzheimer's disease confirmed by cognitive and biomarker tests.
- Have a caregiver who sees the participant at least 3 times per week for 10 hours or more.
- Able to undergo MRI scans and cerebrospinal fluid sampling.
- Body weight between 55 and 110 kg and BMI between 18 and 35 kg/m2.
- Male participants must agree to use contraception or abstain from heterosexual intercourse during and 90 days after the study.
- Female participants must be of non-childbearing potential (at least two years post-menopause or surgically sterile).
- No change in acetylcholinesterase inhibitors or memantine for six months prior and not expected to start during the study.
- Provide written informed consent along with caregiver consent.
You will not qualify if you...
- History or presence of significant health conditions affecting drug metabolism or posing risk during the study.
- Changes in cognitive scores or inconsistent disease classification between screening and baseline.
- Diagnosis of dementia-related diseases other than Alzheimer's disease.
- Unable to tolerate or contraindicated for spinal puncture or MRI.
- Major brain structural diseases or intracranial pathology explaining cognitive impairment.
- History of central nervous system trauma or infections affecting cognition.
- History of seizures except resolved childhood febrile or metabolic seizures.
- Autoimmune disorders, active infections, or use of immunosuppressants.
- Significant liver disease or abnormalities.
- Abnormal thyroid function unless stable on treatment.
- Residing in nursing homes needing continuous medical care.
- History of psychiatric conditions such as schizophrenia or bipolar disorder.
- Current or recent participation in other clinical trials or strong medication interactions.
- Laboratory abnormalities deemed clinically significant.
- Sensitivity or allergy to study interventions.
- Regular use of drugs of abuse in the past 3 years.
- Inability to withhold certain CNS medications prior to testing.
- Positive tests for SARS-CoV-2, hepatitis, HIV, or syphilis.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 6 weeks
Participants receive NTRX-07 or placebo orally once daily to evaluate safety, tolerability, and pharmacokinetics.
Weekly visits for up to 6 weeks
Trial Site Locations
Total: 6 locations
1
Neuro Health Centrum s.r.o.
Brno, Czechia, 628 00
Actively Recruiting
2
Neuropsychiatrie s.r.o.
Prague, Czechia, 160 00
Actively Recruiting
3
Semmelweis University
Budapest, Hungary, 1083
Not Yet Recruiting
4
Semmelweis University
Budapest, Hungary, 1145
Not Yet Recruiting
5
Szpital Uniwersytecki W Krakowie
Krakow, Poland, 30-688
Actively Recruiting
6
Wrocławskie Centrum Alzheimerowskie
Wroclaw, Poland, 53-659
Actively Recruiting
Research Team
J
Joseph Foss, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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