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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

A multiple-ascending dose study of RO7126209 in patients with prodromal or mild to moderate Alzheimer's disease

Luka Kulic MD

F. Hoffmann-La Roche

1-1 NIHONBASHI-MUROMACHI 2-CHOME, CHUO-KU, Tokyo

clinical-trials@chugai-pharm.co.jp

Clinical trials information

Chugai Pharmaceutical Co., Ltd.

1-1 NIHONBASHI-MUROMACHI 2-CHOME, CHUO-KU, Tokyo

+81-120189706

clinical-trials@chugai-pharm.co.jp

Not Recruiting

Sept. 30, 2023

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

treatment purpose

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 (including lacunar infarcts in the cerebellum), 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/dL"

Both

Alzheimer's disease

RO7126209: Part1:RO7126209/Placebo will be administered intravenously as specified in each treatment arm. Part2:RO7126209/Placebo will be administered intravenously as specified in each treatment arm. Part3:RO7126209 will be administered intravenously as specified in each treatment arm. Part4:RO7126209 will be administered intravenously as specified in each treatment arm.

safety
Part1, 2, 3 and 4:Percentage of Participants With Adverse Events (AEs)
Part3:Change From Baseline in Brain Amyloid Load as Measured by Amyloid Positron Emission Tomography (PET) Scan "

phamacokinetics, phamacodynamics, other
1.Change From Baseline in Brain Amyloid Load as Measured by Amyloid Positron Emission Tomography (PET) Scan
2.Plasma Concentration of RO7126209
3.Cerebral Spinal Fluid (CSF) Concentration of RO7126209
4.Number of Participants With Anti-Drug Antibodies (ADAs) to RO7126209

+81-75-572-6331

Mar. 30, 2023

Yes

Qualified researchers may request access to individual patient level data through the clinical study data request platform. For further details on Chugai's Data Sharing Policy and how to request access to related clinical study documents, see here (www.chugai-pharm.co.jp/english/profile/rd/ctds_request.html).

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