A two-part parallel group study to assess the safety, tolerability and pharmacokinetic (PK) profile of multiple oral doses of RDN-929 in healthy older adults and subjects with early symptomatic Alzheimer*s Disease

A two-part parallel group study to assess the safety, tolerability and pharmacokinetic (PK) profile of multiple oral doses of RDN-929 in healthy older adults and subjects with early symptomatic Alzheimer*s Disease - RDN-929-103 (CS0317)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON48424

Enrollment

Registered

2019-04-30

Start date

2019-06-04

Completion date

Unknown

Last updated

2025-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer's Disease Alzheimer's Disease neurodegenerative diseases

Interventions

RDN-929 and matching placebo

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Adult males or postmenopausal or surgically sterile females age 55 * 85 years old for Part 1 and age 50-85 years old for Part 2, inclusive, at the time of informed consent. Body mass index (BMI) *18.0 kg/m2,

Exclusion criteria

Exclusion criteria: History or current evidence of any clinically significant cardiovascular, endocrinologic, hematologic, hepatobiliary, immunologic, metabolic, urologic, pulmonary, neurologic (except for diagnosis of AD in Part 2), renal, or other major disease, as determined by the Investigator. Any conditions that, in the opinion of the Investigator, would make the subject unsuitable for enrollment or could interfere with the subject*s participation in or completion of the study. Further exclusion criteria can be found in the protocol section 8.5.2

Design outcomes

Secondary

Measure	Time frame
Secondary Endpoints: Plasma PK and CSF parameters of RDN-929 such as Cmax and AUC as appropriate. Exploratory Endpoints: Part 1 and 2: PD parameters including selected biomarkers (within group changes and mean group differences). Part 1: PD parameters including PBMC post-translational modification (changes over time and mean group differences) Part 2: Quantitative Electroencephalography (qEEG), including resting state power spectral density (PSD), functional connectivity and Event Related Potential (ERP) acquired during neurocognitive tasks. Mean change in [11C]-UCB-J binding in pre-defined brain regions from baseline (Part 2 only) as measured by PET imaging.	—

Measure

Time frame

Secondary Endpoints: Plasma PK and CSF parameters of RDN-929 such as Cmax and AUC as appropriate. Exploratory Endpoints: Part 1 and 2: PD parameters including selected biomarkers (within group changes and mean group differences). Part 1: PD parameters including PBMC post-translational modification (changes over time and mean group differences) Part 2: Quantitative Electroencephalography (qEEG), including resting state power spectral density (PSD), functional connectivity and Event Related Potential (ERP) acquired during neurocognitive tasks. Mean change in [11C]-UCB-J binding in pre-defined brain regions from baseline (Part 2 only) as measured by PET imaging.

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Primary

Measure	Time frame
Primary Endpoints: Safety parameters include adverse events (AEs), serious adverse events (SAEs), physical and neurological examination, clinical laboratory values, vital signs, 12-lead ECG, and C-SSRS scores.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)