primaryTo assess the safety and tolerability of multiple, once-daily oral doses of RDN-929 over 28 days in healthy older adult subjects and early symptomatic AD subjects.secondaryTo assess the plasma and CSF pharmacokinetics (PK) of RDN-929 in…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Alzheimer's Disease
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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.
Secondary outcome
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.
Background summary
RDN-929 is not yet registered as medicine. This drug is being developed for the
treatment of so-called neurodegenerative diseases. An example of a
neurodegenerative disease is the Alzheimer's Disease. During this disease, the
connections between the neuronal cells in the brain damage, which will
eventually lead to neuronal cell death. The loss of these cells eventually
causes the brain to dysfunction, leading to several mental and physical sympoms
as a result. RDN-929 possibly improves the connections between these neuronal
cells, so that the brain will function better. Previous research in animals
showed that, after RDN-929 administration, the amount of connections between
neuronal cells did indeed increase.
Study objective
primary
To assess the safety and tolerability of multiple, once-daily oral doses of
RDN-929 over 28 days in healthy older adult subjects and early symptomatic AD
subjects.
secondary
To assess the plasma and CSF pharmacokinetics (PK) of RDN-929 in healthy older
adult subjects and early symptomatic AD subjects
Exploratory
Part 1: To explore the pharmacodynamics (PD) of RDN-929 in blood through
analysis of peripheral blood mononuclear cells (PBMC) as well as synaptic and
neuronal biomarkers in plasma and CSF in healthy older adult subjects.
Part 2:
To explore the pharmacodynamics (PD) of RDN-929 through analysis of synaptic
and neuronal biomarkers in plasma and CSF in early symptomatic AD subjects.
To explore the change from baseline in quantitative Electroencephalography
(qEEG) in early symptomatic AD subjects.
To assess the mean change from baseline in radioligand [11C]-UCB-J binding in
pre-defined brain regions as measured by PET imaging in early symptomatic AD
subjects.
Part 1 and 2:
To explore the change from baseline in clinical measures of cognition in
healthy older adult subjects and early symptomatic AD subjects.
Study design
Three (3) center, randomized, double-blind, parallel, 28-day, 4-arm study in
healthy older adults (Part 1) and an open label, single arm, 28-day study in
early symptomatic AD subjects (Part 2).
Intervention
RDN-929 and matching placebo
Study burden and risks
This study is being conducted in healthy volunteers and mild-to-moderate
Alzheimer diseased volunteers. There are no anticipated benefitis or risks of
the ligand [11C]-UCB-J Please see IMPD and IB for further information.
Winter Street 852
Waltham, MA 02451
US
Winter Street 852
Waltham, MA 02451
US
Listed location countries
Age
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
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2019-000831-26-NL |
| CCMO | NL69548.056.19 |