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Alzheimer DiseasePhase 1/2NCT06995573

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

A Phase 1/2 study testing NSC001 in people with Alzheimer Disease, run by NSC-Therapeutics at 10 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 50 to 85 years
Conditions the study is for
Alzheimer Disease
What is being tested?
NSC001
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
90 participants
Where
10 sitesin 2 countries
Study dates
25 Aug 2025to 30 Sep 2026
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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:
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  • 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.
  • 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.
  • Sedating antihistamines if taken within 12 hours prior to cognitive testing (Non-sedating antihistamines [e.g., fexofenadine, cetirizine] are allowed).
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • Use of any drug of abuse, including but not limited to, amphetamine, cannabis, cocaine, opiate, propoxyphene, methadone, methaqualone, phencyclidine, or barbiturates.
  • 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:
  • 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.).
  • Other neurodegenerative condition (e.g., Parkinson's disease, Amyotrophic Lateral Sclerosis, etc.).
  • 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.
  • Other CNS diseases (e.g., severe head trauma, tumors, subdural hematoma, or other space-occupying processes, etc.).
  • Seizure disorder, except history of febrile seizures in childhood.
  • 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:
  • Suicide attempt within the past 12 months prior to screening.
  • 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:
  • Respiratory insufficiency.
  • Heart disease (myocardial infarction, unstable angina, heart failure, cardiomyopathy within 6 months before screening).
  • Bradycardia (heartbeat <50/min) or tachycardia (heartbeat >100/min), confirmed by repeat measurement.
  • 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).
  • 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:
  • Participants with cancers in remission ≥5 years prior to screening.
  • Participants with a history of excised or treated basal cell or squamous carcinoma of the skin.
  • 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.

Trial locations and contacts

10 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

Barbara Fridrich, DI contact

004366488869909

bfridrichl@neuroscios.com

Klara Fuereder, MSC contact

00436645472844

kfuereder@neuroscios.com

10 sites in 2 countries

Germany6 sites, 6 recruiting

  • Clinic Altenburger Land GmbH

    Altenburg, 04600

    Conny Sternitzky, 00493447523211, conny.sternitzky@klinikum-altenburgerland.de

    Jörg Berrouschott

    Not yet recruiting

  • Zentrum fuer klinische Forschung Dr. I. Schoell GmbH

    Bad Homburg, 61348

    Elvira Steidl, 004961722679573, Info@forschung-badhomburg.de

    Recruiting

  • University Clinic Köln

    Cologne, 50937

    Kerstin Weiss, 0049221478 ext. 30514, kerstin.weiss@uk-koeln.de

    Özgür Onur

    Recruiting

  • Universitaetsmedizin Goettingen

    Göttingen, 37075

    Inga Zerr, 004905513961805, ingazerr@med.uni-goettingen.de

    Recruiting

  • Dynamikos GmbH Institut fuer Studien zur Psychischen Gesundheit

    Mannheim, 68165

    Georg Adler, 004962140046190, hafke@ispg-mannheim.de

    Recruiting

  • SANOS Clinic

    Ratingen, 40882

    Melanie Kuerten, 004921025643873, mek@sanosclinic.com

    Jens Harmel

    Recruiting

Other trials in Germany

Austria4 sites, 4 recruiting

  • University Hospital Graz

    Graz, Styria, 8036

    Stephan Seiler, 004331638530314, stephan.seiler@medunigraz.at

    Recruiting

  • Medical University Innsbruck

    Innsbruck, 6020

    Samuel Labrecque, MSc, 0043512504 ext. 81553, Samuel.Labrecque@tirol-kliniken.at

    Atbin Djamshidian- Tehrani

    Recruiting

  • Gemeinnuetzige Salzburger Landeskliniken Betriebsgesellschaft GmbH

    Salzburg, State of Salzburg, 5020

    Fabio Rossini, 0043572555, f.rossini@salk.at

    Recruiting

  • Medical University Vienna

    Vienna, 1090

    Sonja Wieszmüller, Bakk.Phil.MA, 0043140400 ext. 31210

    Elisabeth Stögmann

    Recruiting

Other trials in Austria

About this study

Official title: 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

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.

Read the detailed description

NSC001 is an orally administered small molecule rigid cholinergic agonist that has a high selectivity for M1 muscarinic receptors (MI), designed to improve cognitive and behavioral function in patients with Alzheimer's Disease (AD). The primary pharmacology available for NSC001 from preclinical models and studies in healthy volunteers provides a compelling rationale for the evaluation of the safety and tolerability of this compound in patients with mild to moderate AD and for the investigation of NSC001 effects on cognitive function and behavior in such patients.

Being tested
NSC001, Placebo
Keywords
Mild to Moderate Alzheimer's Disease
Medical subject headings
Alzheimer Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NSC001Drug

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

  • PlaceboOther

    matching placebo to NSC001

Study groups in NCT06995573
Study groupRoleWhat they receive
Arm 1Experimental40 mg QD of NSC001
Receives: Drug: NSC001
Arm 2Experimental40 mg QD of NSC001 + 20 mg of Trospium
Receives: Drug: NSC001
Arm 3Placebo comparatorPlacebo: with or without 20 mg of Trospium
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety and tolerability of NSC001

    Number of Adverse Events (AEs) between V1 (Baseline) -V5 (End of Treatment)

    Measured: Week 0 and week16

  2. Safety during the treatment period

    Number of Serious Adverse Events (SAEs) between V1 (Baseline) -V5 (End of Treatment)

    Measured: Week 0 and week16

Secondary outcomes (4)

  1. Maximum concentration in plasma

    Maximum concentration of NSC001 in Plasma, C (max)

    Measured: At week 0, 1, 2, 3, 4, 16 at pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4 and 6 hours)

  2. Time at maximum concentration in plasma

    Time at maximum concentration of NSC001 in Plasma, T(max)

    Measured: At week 0, 1, 2, 3, 4, 16 at pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4 and 6 hours)

  3. Area under the curve

    Area under the curve; Concentration of NSC001 in blood plasma as a function of time.

    Measured: At week 0, 1, 2, 3, 4, 16 at pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4 and 6 hours)

  4. Half Life of NSC001 in plasma

    Half Life of NSC001; The time it takes for the concentration of NSC001 in the plasma to be reduced by 50%

    Measured: At week 0, 1, 2, 3, 4, 16 at pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4 and 6 hours)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 May 2025
  2. Study start25 Aug 2025
  3. Primary completion30 Jul 2026 (estimated)
  4. Study completion30 Sep 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
90 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06995573
Sponsor's protocol ID
NSC24001
Other IDs
2024-518563-35-00
Status last verified
Apr 2026
First submitted
2 Apr 2025
Last updated
17 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Fisher A. Cholinergic modulation of amyloid precursor protein processing with emphasis on M1 muscarinic receptor: perspectives and challenges in treatment of Alzheimer's disease. J Neurochem. 2012 Jan;120 Suppl 1:22-33. doi: 10.1111/j.1471-4159.2011.07507.x. Epub 2011 Nov 28.

    PubMed 22122190

  • Fisher A. Cholinergic treatments with emphasis on m1 muscarinic agonists as potential disease-modifying agents for Alzheimer's disease. Neurotherapeutics. 2008 Jul;5(3):433-42. doi: 10.1016/j.nurt.2008.05.002.

    PubMed 18625455

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing NSC001 in people with Alzheimer Disease, run by NSC-Therapeutics at 10 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 50 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 17 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in Germany, Austria. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Barbara Fridrich, DI (004366488869909, bfridrichl@neuroscios.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety and tolerability of NSC001 (time frame: Week 0 and week16). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06995573, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2026; AzTrials last refreshed its copy on 1 Nov 2026.

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