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

Completed

Conditions: Alzheimer's Disease
neurodegenerative diseases

Registration Number: NL-OMON48424

Lead Sponsor: Rodin Therapeutics, Inc.

Brief Summary: Trial ended prematurely

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 45

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, <35.0 kg/m2.
Further inclusion criteria can be found in the protocol section 8.5.1.

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary Endpoints:<br /><br>Safety parameters include adverse events (AEs), serious adverse events (SAEs),<br /><br>physical and neurological examination, clinical laboratory values, vital signs,<br /><br>12-lead ECG, and C-SSRS scores.</p><br>

Secondary Outcome Measures

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