A multiple-ascending dose study of RO7126209 in patients with prodromal or mild to moderate Alzheimer's disease
- Conditions
- Alzheimer's disease
- Registration Number
- JPRN-jRCT2051230101
- Lead Sponsor
- uka Kulic MD
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 210
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:
-Completed the treatment period in Part 1, Part 2, or Part 3 of the study
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method safety<br>Part1:Percentage of participants experiencing Dose-limiting adverse events (DLAEs)<br>Part1, 2, 3 and 4:Percentage of Participants With Adverse Events (AEs) <br>Part3:Change From Baseline in Brain Amyloid Load as Measured by Amyloid Positron Emission Tomography (PET) Scan
- Secondary Outcome Measures
Name Time Method phamacokinetics, phamacodynamics, other<br>1.Change From Baseline in Brain Amyloid Load as Measured by Amyloid Positron Emission Tomography (PET) Scan<br>2.Plasma Concentration of RO7126209 <br>3.Cerebral Spinal Fluid (CSF) Concentration of RO7126209 <br>4.Number of Participants With Anti-Drug Antibodies (ADAs) to RO7126209