A phase 2a multi-site, randomized, double-blind, dose escalated, placebo-controlled biomarker study to determine the safety, tolerability and biomarker-based efficacy of NPI-001 (AT-001) in subjects with MCI (Mild Cognitive Impairment) or mild dementia due to Alzheimer’s disease (AD) aged 50 to 85 years

Conditions

Alzheimer's Disease

Brief summary

• Treatment-Emergent Adverse Events and Serious Adverse Events., clinical lab values, electrocardiogram, physical examination, vital signs. ARIA MRI classification

Detailed description

• Reduction in toxic amyloid oligomers in plasma samples at 3, 6, 9 and 12 months of therapy., • Reduction in amyloid accumulation in the brain following 12 months of therapy., • Reduction in pTau217 and pTau217/tTau ratio in plasma samples at 3, 6, 9 and 12 months of therapy., • Reduction in NFL in plasma samples at 3, 6, 9 and 12 months of therapy., • Neuropsychological Test Battery (NTB), Change in Clinical Dementia Rating (CDR) Scale, ADAScog and ADL (ADCS-ADL-MCI) following 12 months of therapy., • Plasma 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., • The following PK parameters will be determined: Cmax, Tmax and AUC0-24h.apparent T1/2, • Change from baseline in Clinical Dementia Rating (CDR) Scale, ADAS-Cog, Columbia Suicide Severity Rating Scale (C-SSRS) following 12 months of therapy

Related papers

No related papers found yet.

Papers published before 2007-09-01 may not appear yet. Historical indexing is in progress.

Interventions

DRUGPlacebo white oral tablet with lactose

DRUGmicro-crystalline cellulose

DRUGcroscarmellose sodium and stearic acid as excipients.

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
• Treatment-Emergent Adverse Events and Serious Adverse Events., clinical lab values, electrocardiogram, physical examination, vital signs. ARIA MRI classification	—

Secondary

Measure	Time frame
• Reduction in toxic amyloid oligomers in plasma samples at 3, 6, 9 and 12 months of therapy., • Reduction in amyloid accumulation in the brain following 12 months of therapy., • Reduction in pTau217 and pTau217/tTau ratio in plasma samples at 3, 6, 9 and 12 months of therapy., • Reduction in NFL in plasma samples at 3, 6, 9 and 12 months of therapy., • Neuropsychological Test Battery (NTB), Change in Clinical Dementia Rating (CDR) Scale, ADAScog and ADL (ADCS-ADL-MCI) following 12 months of therapy., • Plasma 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., • The following PK parameters will be determined: Cmax, Tmax and AUC0-24h.apparent T1/2, • Change from baseline in Clinical Dementia Rating (CDR) Scale, ADAS-Cog, Columbia Suicide Severity Rating Scale (C-SSRS) following 12 months of therapy	—

Measure

Time frame

• Reduction in toxic amyloid oligomers in plasma samples at 3, 6, 9 and 12 months of therapy., • Reduction in amyloid accumulation in the brain following 12 months of therapy., • Reduction in pTau217 and pTau217/tTau ratio in plasma samples at 3, 6, 9 and 12 months of therapy., • Reduction in NFL in plasma samples at 3, 6, 9 and 12 months of therapy., • Neuropsychological Test Battery (NTB), Change in Clinical Dementia Rating (CDR) Scale, ADAScog and ADL (ADCS-ADL-MCI) following 12 months of therapy., • Plasma 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., • The following PK parameters will be determined: Cmax, Tmax and AUC0-24h.apparent T1/2, • Change from baseline in Clinical Dementia Rating (CDR) Scale, ADAS-Cog, Columbia Suicide Severity Rating Scale (C-SSRS) following 12 months of therapy

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Countries

Denmark, Iceland

Outcome results

None listed