Actively Recruiting
A Study to Assess Safety and Tolerability and to Explore Efficacy of NSC001 in Mild to Moderate Alzheimer's Disease
Led by NSC-Therapeutics · Updated on 2026-04-17
90
Participants Needed
10
Research Sites
57 weeks
Total Duration
On this page
Sponsors
N
NSC-Therapeutics
Lead Sponsor
N
NeuroScios GmbH
Collaborating Sponsor
AI-Summary
What this Trial Is About
The purpose of this study is to evaluate the safety and tolerability of NSC001 on in patients with mild to moderate Alzheimer's disease and to evaluate the influence of the compound on cognitive function.
CONDITIONS
Official Title
A Study to Assess Safety and Tolerability and to Explore Efficacy of NSC001 in Mild to Moderate Alzheimer's Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants and their trial partner/caregiver can give signed informed consent and comply with trial requirements
- Must have a reliable trial partner with frequent contact (at least 10 hours/week) to support and accompany participant
- Male or female aged 50 to 85 years at time of consent
- Female participants must be post-menopausal for at least 2 years or surgically sterile for at least 6 months
- Male participants with partners of childbearing potential must use reliable contraception during and 6 months after trial
- Clinical diagnosis of mild to moderate Alzheimer's disease dementia (Stage 4 to 5) per NIA-AA 2018 criteria
- Supportive Alzheimer's biomarkers within the last 3 years (CSF, Amyloid PET, or plasma p-tau217 ≥ 2.0 pg/mL)
- Evidence of cognitive decline over the past year
- MRI or CT scan within 12 months consistent with mild to moderate Alzheimer's disease without significant other brain pathologies
- Mini-Mental State Examination score between 18 and 26 at screening
- Modified Hachinski Ischemic Scale of 4 or less unless recent MRI shows no vascular dementia causes
- Use of acetylcholinesterase inhibitors on stable dose for at least 3 months before baseline
- Adequate vision, hearing, and motor function for testing
- Able to swallow size 2 capsules
- In reasonably good health for 21-week participation
- Consent to ApoE genotyping
You will not qualify if you...
- Unable to comply with visit schedule or protocol requirements
- Planned start or recent use of memantine outside stable dosing requirements
- Prior use of anti-beta-amyloid immunotherapy or vaccines
- Participation in other investigational drug trials within past 3 months
- Use of anticholinergics including trospium within 2 weeks prior to screening
- Use of certain medications affecting cognition or sedation unless stable and allowed
- Use of levodopa or anti-Parkinsonian drugs
- Recent use of prescription narcotics except allowed short-term use
- Use of drugs with known QT-prolonging effects unless stable and monitored
- Use of drugs of abuse
- Use of certain centrally active antihypertensive drugs
- Hospitalization or medication changes within 4 weeks prior to screening
- Other primary degenerative dementias or neurodegenerative conditions
- Cerebrovascular disease with major infarcts or extensive lesions
- Other CNS diseases such as severe head trauma or tumors
- Seizure disorders except febrile seizures in childhood
- Infectious, metabolic, or systemic diseases affecting CNS
- Active major depression, schizophrenia, bipolar disorder, or suicide risk
- Substance abuse within past 12 months or positive drug/alcohol tests
- Significant acute or chronic infections including HIV, hepatitis B or C
- Significant unstable or advanced diseases affecting safety or assessment
- Impaired renal function (creatinine clearance ≤60 mL/min)
- Uncontrolled diabetes (HbA1c >8.5%)
- Chronic liver disease or significant liver function abnormalities
- History of certain cancers unless in remission or treated under specified conditions
- Allergy to trial intervention components
- Conditions making participant unsuitable per Investigator
- Legal or dependent status affecting participation
- Pregnant or breastfeeding females or males with partners who are pregnant or breastfeeding
- Contraindications to MRI if required
- Contraindications to trospium chloride or related conditions
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 10 locations
1
Gemeinnuetzige Salzburger Landeskliniken Betriebsgesellschaft GmbH
Salzburg, State of Salzburg, Austria, 5020
Actively Recruiting
2
University Hospital Graz
Graz, Styria, Austria, 8036
Actively Recruiting
3
Medical University Innsbruck
Innsbruck, Austria, 6020
Actively Recruiting
4
Medical University Vienna
Vienna, Austria, 1090
Actively Recruiting
5
Clinic Altenburger Land GmbH
Altenburg, Germany, 04600
Not Yet Recruiting
6
Zentrum fuer klinische Forschung Dr. I. Schoell GmbH
Bad Homburg, Germany, 61348
Actively Recruiting
7
University Clinic Köln
Cologne, Germany, 50937
Actively Recruiting
8
Universitaetsmedizin Goettingen
Göttingen, Germany, 37075
Actively Recruiting
9
Dynamikos GmbH Institut fuer Studien zur Psychischen Gesundheit
Mannheim, Germany, 68165
Actively Recruiting
10
SANOS Clinic
Ratingen, Germany, 40882
Actively Recruiting
Research Team
B
Barbara Fridrich, DI
CONTACT
K
Klara Fuereder, MSC
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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