Extension Study of Participants From SPG302-ALZ-101

Spinogenix

Status and phase: Invitation-only; Phase 2

Conditions: Alzheimer's Disease

Treatments: Drug: SPG302

Study type: Interventional

Funder types: Industry

Identifiers

NCT06833281

SPG302-ALZ-102 OLE

Details and patient eligibility

About

This study will evaluate the long-term safety and efficacy of participants enrolled in SPG302-ALZ-101 with mild to moderate Alzheimer's Disease (AD)

Full description

This is an open-label extension study of SPG302-ALZ-101 to investigate the long-term safety, tolerability, and efficacy of SPG302 administered orally in participants with mild-to-moderate AD. Enrolled participants will continue at the dose they received at the end of the first trial, and will self-administer SPG302 orally every day for up to 52 weeks. Participants will have an in-person clinic visit every 3 months (± 3 days) and a monthly phone visit. An end of treatment visit will occur within 7 days of the last dose of SPG302. A final visit to collect safety data will be conducted up to 1 month (± 3 days) post last dose.

Enrollment: 24 estimated patients

Sex: All

Ages: 45 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of mild to moderate AD
• Clinical laboratory values within normal range or < 1.5 times ULN
• Life expectancy of >2 years
• Able and willing to provide written informed consent
• Must have participated in all study activities of SPG302-ALZ-101, the parent study

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: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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24 participants in 1 patient group

Open Label Extension

Experimental group

Description:

Active SPG302 to be administered to adult participants with AD who completed initial study. Dose to be administered to be dose received during previous study.

Treatment:

Drug: SPG302