Clinical trial NCT06427668: Study of SPG302 in Adult Participants With Mild-to-Moderate Alzheimer's Disease (AD)
Official title: A Phase 2, Randomized, Placebo-controlled, Double-Blind Multicenter Study to Assess the Safety, Tolerability, and Pharmacodynamics (PD) in Adult Participants With Mild-to Moderate Alzheimer's Disease (AD) Administered SPG302
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Alzheimer Disease
Keywords: Alzheimer Disease
synapse
neural connectivity
Dementia
Lead sponsor: Spinogenix
Sponsor class: INDUSTRY
First posted: 2024-05-24
Enrollment: 24
Sex: ALL
Minimum age (years): 45
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Phase 2 randomized, double-blind, placebo-controlled safety and tolerability study in adult participants with Alzheimer's Disease
Primary purpose: TREATMENT

Brief summary: This phase 2 study will evaluate the safety, tolerability, clinical efficacy, pharmacokinetics, and pharmacodynamics of SPG302 in adult participants with mild-to-moderate AD.

Detailed description: This is a phase 2, multicenter study to assess the safety, tolerability, CNS effects, pharmacokinetics, pharmacodynamics and clinical efficacy of SPG302 in adult participants with mild-to-moderate AD. The study will consist of 2 parts:

Part A: Placebo-controlled, randomized, safety and preliminary efficacy cohort with daily dosing for 28 day cycles

Part B: a randomized expansion cohort of daily dosing for 28 day cycles

Eligibility criteria: Inclusion Criteria:

* Age 45-85
* Diagnosis of mild to moderate AD
* Clinical laboratory values within normal range or \< 1.5 times ULN
* If receiving AD-specific treatment, have been on stable dose for ≥ 3 months prior to first dose of study drug.
* Life expectancy of \>2 years
* Able and willing to provide written informed consent

Exclusion Criteria:

* Any physical or psychological condition that prohibits study completion
* Known cardiac disease
* Active or history of malignancy in the past 5 years
* Serious infection that will not be resolved by first day of study intervention.
* History of clinically significant CNS event or diagnosis in the past 5 years.
* Acute illness within 30 days of Day 1
* History of suicidal behavior or suicidal ideation
* History of chronic alcohol use or substance abuse in the last 5 years
* HIV, hepatitis B and/or hepatitis C positive
* Vaccines within 14 days
* Receipt of investigational products within 30 days
* Blood donation within 30 days
* Pregnant or breastfeeding

Primary outcomes:
measure: Change in Electroencephalogram (EEG) at resting state and at auditory evoked P300 from baseline to endpoint
timeFrame: 8 months
measure: Change in Alzheimer's Disease Assessment Scale-Cog (ADAS-COG) total score from baseline to endpoint
timeFrame: 8 months
measure: Change in Mini-Mental State Examination (MMSE) from baseline to endpoint
timeFrame: 8 months
measure: C-SSRS (Columbia Suicide Severity Rating Scale)
timeFrame: 8 months
measure: Change in Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change (ADCS - CGIC) from baseline to endpoint
timeFrame: 8 months
measure: Change in Alzheimer's Disease Cooperative Study - Activities of Daily Living Scale from baseline to endpoint
timeFrame: 8 months
measure: Quality of Life in Alzheimer's Disease (QOL-AD) from baseline to endpoint
timeFrame: 8 months
Secondary outcomes:
measure: Safety and tolerability of SPG302
timeFrame: 8 months
measure: Plasma pharmacokinetics of SPG302 in participants with AD-Maximum Plasma Concentration (Cmax)
timeFrame: 8 months
measure: Change in biomarkers in participants with AD from baseline to endpoint.
timeFrame: 8 months
Other outcomes:
Locations:
city: Sydney
country: Australia
facility: St Vincent's Hospital
state: New South Wales
city: Adelaide
country: Australia
facility: Flinders Medical center
state: South Australia
Study officials:
affiliation: Flinders Medical Center, Adelaide, SA, Australia
name: Lauren Priest, MBBS
role: PRINCIPAL_INVESTIGATOR
affiliation: St Vincents Hospital, Sydney, NSW, Australia
name: Brew Brew, MBBS,MD,DSC
role: PRINCIPAL_INVESTIGATOR
References: