Recruiting PHASE1, PHASE2 Alzheimer Disease

Tests treatment safety and results for Alzheimer Disease

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

ClinicalTrials.gov ID: NCT06995573

What this study is testing

What is NSC001?

NSC001 is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for alzheimer disease.

Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing
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.
  • Phase 2: a mid-size study of how well it works

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 50 to 85

You may be able to join if

  • Participants and competent trial partner/caregiver are willing and able to give signed informed consent for participation in the trial including...
  • Must have an informant or trial partner who, in the Investigator's judgment, has frequent and sufficient contact with the participant (at least 10...
  • 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...
  • Male trial participants with partners who are women of childbearing potential (WOCBP) must agree to use a reliable means of contraception (e.g...

You likely can't join if

  • Inability to comply with visit schedule or other protocol requirements and failure to perform screening and baseline first treatment visit (V1)...
  • 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...
  • 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...
  • Current use of anticholinergics, including trospium within the past 2 weeks before screening.
  • Use of the following medications:
See the full eligibility criteria
Who can 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...
  • 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...
  • 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...
  • 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...
  • 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...
  • 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.
What rules you out
  • 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...
  • 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...
  • Current use of anticholinergics, including trospium within the past 2 weeks before screening.
  • Use of the following medications:
  • 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...
  • 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...
  • 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...
  • 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...
  • 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...
  • 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...
  • 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...
  • 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...
  • 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...
  • 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...
  • 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...
  • Respiratory insufficiency.
  • Heart disease (myocardial infarction, unstable angina, heart failure, cardiomyopathy within 6 months before screening).
  • Bradycardia (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...
  • 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...
  • 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...

The study team makes the final eligibility decision.

Where it's taking place

  • Salzburg, State of Salzburg, Austria
  • Graz, Styria, Austria
  • Innsbruck, Austria
  • Vienna, Austria
  • Altenburg, Germany
  • Bad Homburg, Germany
  • Cologne, Germany
  • Göttingen, Germany
  • Mannheim, Germany
  • Ratingen, Germany

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 50 years to 85 years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Salzburg, State of Salzburg, Austria; Graz, Styria, Austria; Innsbruck, Austria; Vienna, Austria; Altenburg, Germany; Bad Homburg, Germany and 4 more location(s). Enter your location above to see the nearest site and check your eligibility.

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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.