Brainshuttle AD: A Multiple Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7126209 Following Intravenous Infusion in Participants With Prodromal or Mild to Moderate Alzheimer's Disease

Phase 1

Recruiting

• Conditions: Alzheimer's disease; MedDRA version: 20.0Level: LLTClassification code: 10001896Term: Alzheimer's disease Class: 10029205; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: CTIS2023-509678-52-00
• Lead Sponsor: F. Hoffmann-La Roche AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-01-29
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 256

Inclusion Criteria

1. Age 50 to 85 years (inclusive) at screening, 2. Probable mild to moderate AD dementia (consistent with NIA-AA core clinical criteria for probable AD dementia) (McKhann et al 2011) or prodromal AD (consistent with the NIA-AA diagnostic criteria and guidelines for mild cognitive impairment due to AD) (Albert et al 2011), 3. Mini-Mental State Examination (MMSE) score of 18 to 28 points, inclusive, within 84 days before baseline, 4. Clinical Dementia Rating-Global Score (CDR-GS) of 0.5, 1, or 2 within 84 days before baseline, 5. Positive amyloid PET scan (cut-off: > 50 Centiloid units) within 12 months before baseline, 6. In case of treatment with symptomatic AD medications, dosing regimen must be stable for at least 8 weeks prior to baseline and until randomization

Exclusion Criteria

1. Any condition other than AD that may affect cognition, 2. Significant cerebral abnormalities, 3. History or presence of intracranial mass (e.g., glioma, meningioma) that could potentially impair cognition, 4. History of schizophrenia, schizoaffective disorder, major depression, or bipolar disorder, Cancer, unless cured or currently not needing treatment. Note: History of major depression is acceptable, if participant has had no episode within the past year, or is considered in remission, or depression is controlled by treatment, 5. History of any clinically significant hematological diseases, clinically significant ophthalmologic disease or chronic kidney disease, 6. Atrial fibrillation, cardiovascular disease or uncontrolled hypertension

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified