Alzheimer's Disease alzheimer's disease neurodegenerative diseases
Conditions
Interventions
RDN-929
Matching placebo
Sponsors
Rodin Therapautics, Inc.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Subjects must understand the nature of the study and must provide signed and dated written informed consent in accordance with local regulations before the conduct of any study-related procedures. Subjects must have the ability to communicate well with the Investigator in the local language and be willing to comply with the study restrictions. Subjects must agree not to post any personal medical data related to the study or information related to the study on any website or social media site (e.g., Facebook, Twitter, etc.) until the trial has completed.;For more inclusion criteria, please refer to the protocol.
Exclusion criteria
Exclusion criteria: A positive urine drug screen/alcohol breath test at Screening or Day -1. Acute suicidality or history of suicidal behavior. A positive test for human immunodeficiency virus (HIV) antibody at screening.;For more exclusion criteria, please refer to the protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety parameters include adverse events (AE), physical and neurological examination, clinical laboratory values, orthostatic vital signs, 12-lead ECG, 3-lead ECG (telemetry), C-SSRS scores (Part 3 only), VAS for nausea (Part 1 and Part 3 only), and VAS for headache (Part 1 and Part 3 only). | — |
Secondary
| Measure | Time frame |
|---|---|
| Plasma PK parameters of RDN-929 and ROD-1610 including Cmax, Tmax, Cavg (Part 3 only), Cmin (Part 3 only), AUC0-t (Part 3 only), AUClast (Parts 1 and 2 only), AUC0-inf, AUCtau (Part 3 only), %AUCextrap (Parts 1 and 2 only), t1/2, *z, AI (Part 3 only) and MR. | — |
Countries
Netherlands
Outcome results
None listed