ACETYLCYSTEINE AMIDE for Mild cognitive impairment | Alzheimer's disease

Inclusion criteria

• {"criterion_text":"- Subject is male or female, aged 50 or older but younger than 85.\n- Subject has a pTau 217 value of > 0.35 pg/ml\n- Subject has MCI or mild dementia due to Alzheimer´s disease according to Jack 2024 with a CDR of 0.5 or 1.0 receiving standard AD care\n- Subject is willing to have a baseline and follow up blood tests according to the schedule of assessments, for up to 12 months.\n- Subject is willing and able to undergo MRI, and amyloid PET scan evaluations of the brain which fulfil the following requirements:a.PET amyloid brain load >32 centiloids b. MRI <8 micro bleeds.\n- Subject has provided informed consent for participation in trial.\n- Subject has a spouse/close relative/caregiver as study partner who lives with or supervises subject care.\n- Subject has an MMSE score of >21 < 28\n- If taking concomitant medications, treated with stable doses of drugs essentially required for chronic medical conditions which do not lead to exclusion, during a period of at least 3 months prior to screening, and dose regimen is expected to remain stable during the conduct of the study.\n- Subject is able to read, write, speak clearly for the cognitive tests, with eyesight and hearing sufficient to enable completion of the cognitive tests."}

Exclusion criteria

• {"criterion_text":"- Subject has MRI evidence evaluated by central read of a. Brain abnormality caused by other neurological disease than AD including but not limited to vascular disease (vascular dementia), acute or subacute cerebral hemorrhage, large-vessel stroke, brain tumors, inflammatory immunological or metabolic disorders. b. more than 7 microbleeds, multiple lacunes or any lacune in strategically important location, Grade 2 and 3 white matter lesions, any focal area of superficial siderosis or medical implants or foreign bodies unsuitable for MRI.\n- Known or recently suspected (3 months) excessive alcohol or drug abuse.\n- There is any concern by the investigator regarding the patient’s safety, compliance, or suitability with respect to his/her participation in the study.\n- Use of NAC or other investigational drugs at the time of enrollment, or within 5 half-lives of enrollment, or within 14 days, whichever is longer.\n- Subject has moderate or severe dementia, defined as CDR of ≥ 2.0\n- History of liver disease\n- Any suicidal ideation or suicidal behavior in the C-SSRS (C-SSRS score > 0)\n- Subjects who are or have been on AD immunotherapy.\n- Subject has MRI evidence of vascular disease (vascular dementia).\n- Subject has clinically significant illness, mental or physical, that, in the opinion of the investigator, might confound the results of the study, pose additional risk to the patient by their participation, or prevent/impede the patient from completing the study.\n- Subject has known sensitivity to NAC/NACA."}

Primary endpoints

• {"endpoint_text":"- •\tTreatment-Emergent Adverse Events and Serious Adverse Events., clinical lab values, electrocardiogram, physical examination, vital signs. ARIA MRI classification","definition_or_measurement_approach":"Monitoring of Treatment-Emergent Adverse Events and Serious Adverse Events; clinical laboratory evaluations; electrocardiogram; physical examination; vital signs; ARIA MRI classification."}

Secondary endpoints

• {"endpoint_text":"- •\tReduction in toxic amyloid oligomers in plasma samples at 3, 6, 9 and 12 months of therapy.","definition_or_measurement_approach":"Measurement of toxic amyloid oligomers in plasma at months 3, 6, 9 and 12."}
• {"endpoint_text":"- •\tReduction in amyloid accumulation in the brain following 12 months of therapy.","definition_or_measurement_approach":"Assessment of brain amyloid accumulation after 12 months of therapy (amyloid PET imaging)."}
• {"endpoint_text":"- •\tReduction in pTau217 and pTau217/tTau ratio in plasma samples at 3, 6, 9 and 12 months of therapy.","definition_or_measurement_approach":"Measurement of plasma pTau217 and tTau and calculation of pTau217/tTau ratio at months 3, 6, 9 and 12."}
• {"endpoint_text":"- •\tReduction in NFL in plasma samples at 3, 6, 9 and 12 months of therapy.","definition_or_measurement_approach":"Measurement of plasma neurofilament light (NFL) at months 3, 6, 9 and 12."}
• {"endpoint_text":"- •\tNeuropsychological Test Battery (NTB), Change in Clinical Dementia Rating (CDR) Scale, ADAScog and ADL (ADCS-ADL-MCI) following 12 months of therapy.","definition_or_measurement_approach":"Neuropsychological assessments (NTB, CDR scale, ADAS-Cog, ADCS-ADL-MCI) compared to baseline after 12 months."}
• {"endpoint_text":"- •\tPlasma concentrations of NPI-001 will be measured after the first intake of NPI-001 and after 12 months of intake on eight occasions up to 24hr.","definition_or_measurement_approach":"Pharmacokinetic sampling: plasma NPI-001 measured after first dose and after 12 months on eight occasions up to 24 hours."}
• {"endpoint_text":"- •\tThe following PK parameters will be determined: Cmax, Tmax and AUC0-24h.apparent T1/2","definition_or_measurement_approach":"Determination of PK parameters including Cmax, Tmax, AUC0-24h and apparent T1/2 from plasma concentration-time data."}
• {"endpoint_text":"- •\tChange from baseline in Clinical Dementia Rating (CDR) Scale, ADAS-Cog, Columbia Suicide Severity Rating Scale (C-SSRS) following 12 months of therapy","definition_or_measurement_approach":"Change-from-baseline assessments for CDR, ADAS-Cog and C-SSRS at 12 months."}

Iceland

Earliest CTIS Part Ii Submission Date

02-05-2025

Latest Decision Or Authorization Date

22-09-2025

Processing Time Days

143

Number Of Sites

1

Number Of Participants

20

Denmark

Earliest CTIS Part Ii Submission Date

15-04-2025

Latest Decision Or Authorization Date

22-09-2025

Processing Time Days

160

Number Of Sites

3

Number Of Participants

10

Primary sponsor

Full Name

Arctic Therapeutics ehf.

Organisation Type

Pharmaceutical company

Country Of Registered Address

Iceland

Third parties

• {"country":"Denmark","full_name":"Blueskin A/S","duties_or_roles":"Investigator Recruitment; QA/Auditing; Statistical analysis; Medical Expert (additional sponsorDuties codes present)","organisation_type":"SME"}
• {"country":"Iceland","full_name":"Vistor ehf.","duties_or_roles":"sponsorDuties codes: 1, 12, 5","organisation_type":"Pharmaceutical company"}