Study of SPG302 in Adult Participants With Mild-to-Moderate Alzheimer's Disease (AD)

Alzheimer Disease Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06427668
• Other study ID #: SPG302-ALZ-101
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: July 2024
• Est. completion date: June 2026

Study information

• Verified date: June 2024
• Source: Spinogenix
• Contact: Aimee Cayzer
• Phone: +61 482 130622
• Email: RAPMTU[@]sa.gov.au
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 24
• Est. completion date: June 2026
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease

Intervention

Drug:
• SPG302
synthetic small molecule
• Placebo
Placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Spinogenix

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Electroencephalogram (EEG) at resting state and at auditory evoked P300 from baseline to endpoint	Electroencephalogram (EEG) will provide non-invasive measurement of brain activity. This test will be used to measure resting state cognitive activity as well as cognitive activity after auditory stimulation. Sound stimuli is 500Hz and 2000Hz.	8 months
Primary	Change in Alzheimer's Disease Assessment Scale-Cog (ADAS-COG) total score from baseline to endpoint	The Alzheimer's Disease Assessment Scale-Cognitive Subscale test (ADAS-Cog) measures language and memory, focusing on cognitive and non-cognitive functioning. It evaluates word recall, naming of objects, word recognition, comprehension and word finding. The ADAS-COG is scored 0-70. The higher the score the greater the impairment.	8 months
Primary	Change in Mini-Mental State Examination (MMSE) from baseline to endpoint	The Mini-Mental State Exam (MMSE) is a test of cognitive function. It includes tests of orientation, attention, memory, language and visual-spatial skills. The lower the score the greater the impairment.	8 months
Primary	C-SSRS (Columbia Suicide Severity Rating Scale)	Prospective suicidality assessment is performed using the Columbia-Suicide Severity Rating Scale (C-SSRS), a questionnaire to evaluate suicidal ideation and behavior. Answer "yes" on item 4 or 5 of the Suicidal Ideation section or "yes" on any item of the Suicidal Behavior section is considered positive. The suicidal behavior lethality sub-scale inquires about the level of actual or potential medical damage.	8 months
Primary	Change in Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change (ADCS - CGIC) from baseline to endpoint	The Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change (ADCS - CGIC) is a metric for clinical assessment of symptom severity. It consists of 2 parts. First a baseline evaluation of patient and caregiver is performed to collect necessary clinical information. The clinician will then conduct the second phase of the assessment after a specified time period, and changes in symptom severity are indicated on a seven point scale. A higher scale indicates a worsening of symptoms.	8 months
Primary	Change in Alzheimer's Disease Cooperative Study - Activities of Daily Living Scale from baseline to endpoint	The Alzheimer's Disease Cooperative Study - Activities of Daily Living Scale is an scale that assesses the performance of daily tasks and activities. A lower score indicates lower functional performance.	8 months
Primary	Quality of Life in Alzheimer's Disease (QOL-AD) from baseline to endpoint	The Quality of Life in Alzheimer's Disease (QOL-AD) is a test to evaluate the quality of life through a series of questions of ability to complete daily activities and tasks. A lower score indicates lower functional quality of life.	8 months
Secondary	Safety and tolerability of SPG302	Incidence, nature and severity of adverse events (AEs) and serious adverse events (SAEs)	8 months
Secondary	Plasma pharmacokinetics of SPG302 in participants with AD-Maximum Plasma Concentration (Cmax)	Blood will be collected following administration of SPG302 and plasma levels will be evaluated to measure the maximum concentration.	8 months
Secondary	Change in biomarkers in participants with AD from baseline to endpoint.	To assess the effect of SPG302 on Neurofilament light (NfL), a protein elevated in AD. This will be measured in picometers/milliliter.	8 months