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Updated June 2026 · ClinicalTrials.gov

RECRUITINGPhase 1 / Phase 2INTERVENTIONAL

A Study to Assess Safety and Tolerability and to Explore Efficacy of NSC001 in Mild to Moderate Alzheimer's Disease

A Phase 2a, Multi-Center, Randomized, Parallel Group, Double Blind and Placebo-controlled Clinical Trial to Assess Safety and Tolerability as Well as Explorative Efficacy of the Orthosteric Selective Muscarinic M1 Agonist NSC001 in Mild to Moderate Alzheimer's Disease

A Study to Assess Safety and Tolerability and to Explore Efficacy of NSC001 in Mild to Moderate Alzheimer's Disease (NCT06995573) is a Phase 1 / Phase 2 interventional studying Alzheimer Disease, sponsored by NSC-Therapeutics. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

What Stage of Research Is This?

Phase 1 trials test a new treatment for the first time in humans, focusing on safety, dosing, and how the body processes the drug. For Alzheimer Disease, a Phase 1 study typically enrolls a small number of participants — often healthy volunteers or patients who have exhausted standard treatment options. Phase 1 results determine whether a treatment moves into larger Phase 2 efficacy studies.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 90 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Alzheimer Disease subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: - Participants and competent trial partner/caregiver are willing and able to give signed willing to sign a consent form for participation in the trial including compliance with the requirements and restrictions according to local regulations for the trial willing to sign a consent form Form (ICF). Signed willing to sign a consent form by the patient (examined and verified to be mentally capable by an independent physician/ neurologist) prior to the initiation of any study specific procedure. - Must have an informant or trial partner who, in the Investigator's judgment, has frequent and sufficient contact with the participant (at least 10 hours/week), who is considered reliable by the Investigator in providing support to the participant to ensure compliance with the trial intervention, including the proper and consistent intake of the study medication, who can accompany the participant to trial visits and help with protocol procedures, and who is also able and willing to provide input for completing the caregiver scales and sign the caregiver consent form. - Male or female aged 50 to 85 years, inclusive at the time of consent. - Female trial participants must be post-menopausal for at least 2 consecutive years or surgically sterile (bilateral tubal ligation, hysterectomy, or bilateral oophorectomy) for at least 6 months prior to screening. - Male trial participants with partners who are women of childbearing potential (WOCBP) must agree to use a reliable means of contraception (e.g., minimum condom + spermicide) during the trial and 6 months after discontinuing the trial intervention - Participants who have a clinical diagnosis of AD, which falls into the stages of mild to moderate dementia (Stage 4 to 5) according to the utilized by the NIA-AA 2018 criteria at screening. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * Participants and competent trial partner/caregiver are willing and able to give signed informed consent for participation in the trial including compliance with the requirements and restrictions according to local regulations for the trial Informed Consent Form (ICF). Signed informed consent by the patient (examined and verified to be mentally capable by an independent physician/ neurologist) prior to the initiation of any study specific procedure. * Must have an informant or trial partner who, in the Investigator's judgment, has frequent and sufficient contact with the participant (at least 10 hours/week), who is considered reliable by the Investigator in providing support to the participant to ensure compliance with the trial intervention, including the proper and consistent intake of the study medication, who can accompany the participant to trial visits and help with protocol procedures, and who is also able and willing to provide input for completing the caregiver scales and sign the caregiver consent form. * Male or female aged 50 to 85 years, inclusive at the time of consent. * Female trial participants must be post-menopausal for at least 2 consecutive years or surgically sterile (bilateral tubal ligation, hysterectomy, or bilateral oophorectomy) for at least 6 months prior to screening. * Male trial participants with partners who are women of childbearing potential (WOCBP) must agree to use a reliable means of contraception (e.g., minimum condom + spermicide) during the trial and 6 months after discontinuing the trial intervention * Participants who have a clinical diagnosis of AD, which falls into the stages of mild to moderate dementia (Stage 4 to 5) according to the utilized by the NIA-AA 2018 criteria at screening. * Patients who show CSF biomarker data supporting the diagnosis of AD measured within the last 3 years or patients with a positive Amyloid Pet Scan within the last 3 years or have a test on p-tau217 in plasma indicating brain amyloid positivity will qualify for the study. Plasma pTau217 concentration of ≥ 2.0 pg/mL. * Evidence of cognitive decline over the last year must be present based on informant observation, medical records, or objective neurocognitive testing. * Magnetic resonance imaging (MRI) or computed tomography (CT) scan performed within 12 months before screening, with findings consistent with the clinical diagnosis of mild to moderate AD without any other clinically significant comorbid pathologies, especially cerebrovascular lesions. If an MRI or CT scan is unavailable within 12 months before screening, an MRI assessment should be completed, and the findings confirmed before the participant's treatment start (V1). * Mini-Mental State Examination (MMSE) score of ≥18 and ≤26 at screening. * Modified Hachinski Ischemic (mHIS) Scale ≤4 unless recent MRI study demonstrates no vascular causes for dementia. * Use of AChEIs (e.g., donepezil, galantamine, or rivastigmine) is mandatory and treatment must be on a stable dose for at least 3 months prior to baseline * Adequate vision, hearing, and motor function to comply with testing. * Ability to swallow size 2 capsules. * In the opinion of the Investigator is in reasonably good health for 21-week trial participation. * Trial participants must consent to ApoE genotyping. Their ApoE status may be disclosed to the participant at the Investigator's discretion. Exclusion Criteria: * Inability to comply with visit schedule or other protocol requirements and failure to perform screening and baseline first treatment visit (V1) assessments. * Planned start of NMDA receptor antagonist memantine during the trial period (i.e., the next 13 weeks) or use of memantine within the past 4 weeks before screening, unless at a stable dose for at least 8 weeks prior to screening. * Prior use of anti-beta-amyloid immunotherapy (e.g., Aducanumab, Leqanemab, Donanemab) or administration of anti-amyloid vaccine. * Enrollment in another investigational clinical trial and, respectively, administration of investigational drug within the previous 3 months small molecules. Previous participation in investigational clinical trials with monoclonal antibodies against amyloid or other anti-beta amyloid immunotherapy and other biologicals. * Current use of anticholinergics, including trospium within the past 2 weeks before screening. * Use of the following medications: 1. Long-acting benzodiazepines (e.g., valium), except for sedation prior to screening MRI scans for those participants requiring sedation and should not be administered within 24 hours prior to cognitive testing. 2. Short/medium-acting benzodiazepines (e.g., alprazolam, lorazepam, oxazepam, temazepam) except if used chronically for sleep and on a stable dose for ≥4 weeks prior to screening and throughout the trial. May not be taken within 12 hours prior to cognitive testing. 3. Sedating antihistamines if taken within 12 hours prior to cognitive testing (Non-sedating antihistamines \[e.g., fexofenadine, cetirizine\] are allowed). 4. Anticonvulsants that have significant effects on cognition per the Investigator's opinion and/or anticonvulsants used for treatment of seizures. Anticonvulsants with limited cognitive effects, such as lamotrigine, pregabalin, levetiracetam for the treatment of pain, and other non-epilepsy indications are allowed if, in the opinion of the Investigator, they are not producing sedation or contributing to cognitive impairment. The participant must have been on a stable dose for ≥4 weeks prior to screening and throughout the trial. 5. Antidepressants that may, in the Investigator's opinion, affect the participant's cognition (e.g., tricyclic antidepressants). Mild depression or depressive mood arising in the context of AD are not criteria for exclusion. Use of antidepressants is allowed if at stable doses for ≥4 weeks prior to screening and throughout the trial. 6. Antipsychotics used regularly, except for low doses of atypical antipsychotics (e.g., risperidone, aripiprazole, or quetiapine) if used on an as-needed basis or if used at a stable dose for ≥4 weeks prior to screening and throughout the duration of the trial. The definition of "low doses" should be judged by the Investigator, and the Medical Monitor can be consulted if needed. 7. Prior use of levodopa or anti-Parkinsonian medications including dopaminergic agents, amantadine, selegiline, benztropine, and monoamine oxidase (MAO) inhibitors prescribed for the treatment of Parkinsonism or Parkinson's disease. 8. Use of prescription narcotic medications within 4 weeks prior to screening. After randomization, short-term use of prescription narcotics is allowed for specific situations (e.g., after surgical procedures) and if administered at least 24 hours prior to cognitive testing. 9. Use of drugs with known QT-prolonging effects36, unless used at a stable dose for ≥12 weeks prior to screening and throughout the duration of the trial, and with demonstrated stable QT interval on treatment. 10. Use of any drug of abuse, including but not limited to, amphetamine, cannabis, cocaine, opiate, propoxyphene, methadone, methaqualone, phencyclidine, or barbiturates. 11. Centrally active anti-hypertensive drugs (clonidine, l-methyl DOPA, guanidine, guanfacine, etc.). * Hospitalization or change of chronic concomitant medication within 4 weeks prior to screening or during screening period. * Clinical, laboratory or neuro-imaging findings consistent with: 1. Other primary degenerative dementia, (e.g., dementia with Lewy bodies, fronto temporal dementia, Parkinson's disease, Huntington's disease, Creutzfeldt-Jakob's disease, Down's syndrome, etc.). 2. Other neurodegenerative condition (e.g., Parkinson's disease, Amyotrophic Lateral Sclerosis, etc.). 3. Cerebrovascular disease (major infarct, 1 strategic or multiple lacunar infarcts, extensive white matter lesions \>one quarter of the total white matter) based on historical or current CT or MRI. 4. Other CNS diseases (e.g., severe head trauma, tumors, subdural hematoma, or other space-occupying processes, etc.). 5. Seizure disorder, except history of febrile seizures in childhood. 6. Other infectious, metabolic, or systemic diseases affecting the CNS (e.g., syphilis, present hypothyroidism, present vitamin B12 or folate deficiency, serum electrolytes out of normal range, juvenile-onset diabetes mellitus, etc.). * A current Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) diagnosis of active major depression, schizophrenia, or bipolar disorder or are at suicide risk, as determined by meeting any of the following criteria: 1. Suicide attempt within the past 12 months prior to screening. 2. Suicidal ideation as defined by a positive response to questions 4 and 5 on the C-SSRS within 60 days of screening. * Have a history of substance abuse (based on DSM-IV criteria) within the past 12 months prior to screening, a positive urine drug (due to nonprescription drug) or alcohol test at screening, or use of cannabinoids (prescription or recreational). * Significant acute or chronic infection at screening including, among others: History of, or positive test result at screening visit for, human immunodeficiency virus (HIV) or known current hepatitis C or hepatitis B virus infection, or positive test result at screening (defined as hepatitis B virus \[HBV\] surface Ag positive or positive HCV with reflex to positive hepatitis C virus \[HCV\] RNA). * Clinically significant, advanced, or unstable disease that may interfere with primary or secondary variable evaluations, and which may bias the assessment of the clinical or mental status of the trial participant or put the participant at special risk, such as: 1. Respiratory insufficiency. 2. Heart disease (myocardial infarction, unstable angina, heart failure, cardiomyopathy within 6 months before screening). 3. Bradycardia (heartbeat \<50/min) or tachycardia (heartbeat \>100/min), confirmed by repeat measurement. 4. Higher degree AV block (Mobitz type II and III), congenital long QT syndrome, sinus node dysfunction or prolonged QTcF-interval (males \>450 msec and females \>470 msec). 5. Uncontrolled hypertension (\>180/95 mm Hg) or hypotension (\<90/60 mm Hg or higher if symptomatic), confirmed by repeat measurement. * Indication of impaired renal function at screening defined as creatinine clearance ≤60 mL/min according to Chronic Kidney Epidemiology Collaboration (CKD-EPI) formula (confirmed by repeat measurement). * Indication of uncontrolled diabetes at screening defined by HbA1c \>8.5%. * Indication of chronic liver disease, liver function test abnormalities, or other signs of hepatic insufficiency (alanine transaminase \[ALT\], aspartate aminotransferase \[AST\], gamma-glutamyl transferase (GGT), or alkaline phosphatase \[ALP\] \>2.5 upper limit of normal \[ULN\]; confirmed by repeat measurement). * History of pre-malignant or malignant disease. The following exceptions may be made after discussion with the Sponsor: 1. Participants with cancers in remission ≥5 years prior to screening. 2. Participants with a history of excised or treated basal cell or squamous carcinoma of the skin. 3. Participants with localized prostate cancer with treatment cycles that were completed at least 6 months prior to screening. * Suspected or known allergy to any components of the trial interventions. * Any condition, which, in the opinion of the Investigator, makes the trial participant unsuitable for inclusion. * If the trial participant is in any way dependent on the Sponsor or the Investigator or if the trial participant is accommodated in an establishment on a judicial or administrative order. * Female participants who are pregnant or currently breastfeeding or who plan to become pregnant. * Male participants with a partner who is pregnant or currently breastfeeding or who plans to become pregnant. * In case an MRI is needed at screening, contraindications to having a brain MRI (e.g., MRI-incompatible pacemaker, MRI-incompatible aneurysm clips, artificial heart valves, or other metal foreign body; claustrophobia that cannot be medically managed). * Any contraindication to trospium chloride, including known hypersensitivity to trospium chloride or any of the excipients listed in the SmPC, myasthenia gravis, urinary retention, gastric retention, toxic megacolon, ulcerative colitis or uncontrolled narrow-angle glaucoma.

Treatments Being Tested

DRUG

NSC001

rigid, orthosteric acetylcholine analog, highly specific for M1 muscarinic receptor

OTHER

Placebo

matching placebo to NSC001

Locations (10)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Gemeinnuetzige Salzburger Landeskliniken Betriebsgesellschaft GmbH
Salzburg, State of Salzburg, Austria
University Hospital Graz
Graz, Styria, Austria
Medical University Innsbruck
Innsbruck, Austria
Medical University Vienna
Vienna, Austria
Clinic Altenburger Land GmbH
Altenburg, Germany
Zentrum fuer klinische Forschung Dr. I. Schoell GmbH
Bad Homburg, Germany
University Clinic Köln
Cologne, Germany
Universitaetsmedizin Goettingen
Göttingen, Germany
Dynamikos GmbH Institut fuer Studien zur Psychischen Gesundheit
Mannheim, Germany
SANOS Clinic
Ratingen, Germany

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06995573), the sponsor (NSC-Therapeutics), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06995573 clinical trial studying?

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. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06995573?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06995573?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06995573. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06995573. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-06-26 · Data from ClinicalTrials.gov.