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
EU CTIS ID: 2023-509678-52-00
What this study is testing
To evaluate the safety and tolerability of multiple-ascending dose of RO7126209 (Part 1 and 2), of intravenous dose of RO7126209 (Part 3) and of long-term administration of IV doses (Part 4) To evaluate the pharmacodynamic (PD) effects of multiple doses of RO7126209 (Part 3)
- Phase I and Phase II (Integrated)- Other
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- 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
The study team makes the final eligibility decision.
Where it's taking place
- New Zealand
- United Kingdom
- Taiwan
- Brazil
- Chile
- Korea, Republic of
- Australia
- Japan
- Canada
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New Zealand; United Kingdom; Taiwan; Brazil; Chile; Korea, Republic of and 4 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.