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

Spinogenix

Status and phase: Enrolling; Phase 2

Conditions: Alzheimer Disease

Treatments: Drug: SPG302; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06427668

SPG302-ALZ-101

Details and patient eligibility

About

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

Full 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

Enrollment: 24 estimated patients

Sex: All

Ages: 45 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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24 participants in 3 patient groups, including a placebo group

Part A: Active SPG302 to be administered to adult participants with AD

Active Comparator group

Description:

Cohort 1: 12 participants with Alzheimer's Disease will be randomized in a 2:1 ratio to receive SPG302 or placebo. Study intervention will be 300 mg orally once daily for 28 days (cycle 1). All participants will receive open-label SPG302 for cycles 2-7. This arm may be expanded to cohort 2: 12 additional participants pending review of data, for additional dose exploration.

Treatment:

Drug: SPG302

Part A: Placebo comparator to be administered to adult participants with AD

Placebo Comparator group

Description:

Cohort 1: 12 participants with Alzheimer's Disease will be randomized in a 2:1 ratio to receive SPG302 or placebo. Study intervention will be placebo capsule orally daily for 28 days (cycle 1). All participants will receive open-label SPG302 for cycles 2-7. This arm may be expanded to 12 additional participants as cohort 2 pending review of data, for additional dose exploration.

Treatment:

Drug: Placebo

Part B: Expansion Cohort

Experimental group

Description:

Dose to be used and size of dosing cohort to be determined by Data Safety and Monitoring Committee following completion of Part A.

Treatment:

Drug: SPG302