JPRN-jRCT2051230101
Recruiting
Phase 1
A Phase Ib/IIa, Randomized, Double Blind, Placebo-Controlled, Multiple Ascending Dose, Parallel-Group Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7126209 Following Intravenous Infusion in Patients With Prodromal or Mild to Moderate Alzheimer's Disease
uka Kulic MD0 sites210 target enrollmentSeptember 12, 2023
ConditionsAlzheimer's disease
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Alzheimer's disease
- Sponsor
- uka Kulic MD
- Enrollment
- 210
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Key inclusion criteria for part 1, 2 and 3:
- •\-Availability of a person (referred to as the study partner)
- •\-Adequate visual and auditory acuity, in the Investigator's judgment, sufficient to perform the neuropsychological testing (eye glasses and hearing aids are permitted)
- •\-Probable mild to moderate AD dementia (consistent with National Institute on Aging\-Alzheimer's Association \[NIA\-AA] core clinical criteria for probable AD dementia) or prodromal AD (consistent with the NIA\-AA diagnostic criteria and guidelines for mild cognitive impairment due to AD)
- •\-Screening Mini\-Mental State Examination (MMSE) score of 18 to 28 points, inclusive, within 84 days before baseline
- •\-Clinical Dementia Rating\-Global Score (CDR\-GS) of 0\.5, 1, or 2 within 84 days before baseline
- •\-Positive amyloid PET scan (cut\-off: \>50 Centiloid units) within 12 months before baseline
- •\-In case of treatment with symptomatic AD medications, dosing regimen must be stable for at least 8 weeks prior to baseline and until randomization
- •\-Agree to apolipoprotein E (APOE) genotyping
- •Inclusion criteria for Part 4:
Exclusion Criteria
- •Key exclusion criteria for part1, 2 and 3:
- •\-Any evidence of other relevant neurological condition, including other (non\-AD) neurodegenerative and neuropsychiatric conditions, neurovascular brain disorders, seizure disorders, inflammatory and infectious disorders of the central nervous system, trauma and delirium, among several others
- •\-History of hypersensitivity to biologic agents or any of the excipients in the formulation
- •\-MRI exclusion criteria: \>2 lacunar infarcts, any territorial infarct \>1 cm^3, any white matter lesion that corresponds to an overall Fazekas score of 3 that requires at least one confluent hyperintense lesion on the fluid\-attenuated inversion recovery (FLAIR) sequence, which is 20 mm or more in any dimension
- •Exclusion criteria for Part 4:
- •\-Prematurely discontinued from the treatment period for study for any reason or meeting discontinuation criteria before the baseline visit of Part 4\.
- •\-Any drop in hemoglobin of \> 20% compared to baseline or hemoglobin value below 10 g/d
Outcomes
Primary Outcomes
Not specified
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