SLS-005 (Trehalose Injection) in the Treatment of Alzheimer's Disease
- Conditions
- Alzheimer's Disease
- Interventions
- Drug: SLS-005 - Twice WeeklyDrug: SLS-005 - Once Weekly
- Registration Number
- NCT05332678
- Lead Sponsor
- Seelos Therapeutics, Inc.
- Brief Summary
An open-label, proof-of-concept study to evaluate the safety and treatment effects of SLS-005 in Participants with Alzheimer's Disease (AD) treated once or twice weekly for 52 weeks.
- Detailed Description
This is an open-label proof-of-concept study to evaluate the safety and treatment effects of SLS-005 (trehalose injection, 90.5 mg/mL for intravenous infusion) administered by IV infusion in either a once weekly or twice weekly dosing regimen in eligible men and women, ages 50-85 years, who have very mild, mild, or moderate dementia as determined by the Clinical Dementia Rating (CDR) global score and a biomarker-supported diagnosis of AD guided by the National Institute on Aging and Alzheimer's Association (NIA-AA) Research Framework.
The study will enroll approximately 30 eligible participants who will be assigned in a 1:1 ratio to treatment with SLS-005 at a dose of 0.75 g/kg. administered by intravenous (IV) infusion in either a once weekly or twice weekly dosing regimen for up to 52 weeks. Participants will be assigned to 1 of the 2 dosing regimens to achieve approximately equal numbers of participants with mild (CDR 0.5 or 1) and moderate (CDR 2) baseline dementia severity in each dosing regimen. A relatively equal number of participants enrolled in each dosing regimen will be assigned to either the amyloid or tau PET procedure. Tracers to be used will be approved by Sponsor and described in the imaging manual.
Adverse events and results of laboratory and physical evaluations will be collected and assessed throughout the study. Fluid biomarkers associated with AD pathology, brain imaging including amyloid or tau PET and volumetric magnetic resonance imaging (MRI), and measures of cognitive performance, functioning in activities of daily living (ADL), and neuropsychiatric behavioral symptoms will be collected at baseline and at scheduled times throughout the study. Participants who terminate treatment early, will be encouraged to complete all safety and outcome procedures as specified in the protocol's schedule of events.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description SLS-005 - Twice Weekly SLS-005 - Twice Weekly SLS-005 (trehalose injection, 90.5 mg/mL for intravenous infusion). SLS-005 will be administered as a weight-based dose of 0.75 g/kg by IV infusion twice a week over 60 ± 5 minutes for volumes \<600 mL or 90 minutes +5 min for volumes \>600 mL. For 52 weeks. SLS-005 - Once Weekly SLS-005 - Once Weekly SLS-005 (trehalose injection, 90.5 mg/mL for intravenous infusion). SLS-005 will be administered as a weight-based dose of 0.75 g/kg by IV infusion once a week over 60 ± 5 minutes for volumes \<600 mL or 90 minutes +5 min for volumes \>600 mL. For 52 weeks.
- Primary Outcome Measures
Name Time Method Endpoints for Safety and Tolerability of Treatment 52 weeks Incidences of treatment-emergent early study and treatment discontinuations.
- Secondary Outcome Measures
Name Time Method Endpoints for Treatment Effects on Imaging Biomarkers Associated with AD 26 and 52 weeks Changes in brain imaging biomarkers associated with AD
Exploratory Endpoints - Treatment Effects in Cognitive Performance 13, 26, 39 and 52 weeks Changes from baseline in cognitive performance as measured by the Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog 13). ADAS-Cog 13 is a series of questions to the participant and tasks for the participant to perform. It is used to measure cognitive functions and non-cognitive functions such as mood and behaviour
Endpoints for Treatment Effects on CSF Biomarkers Associated with AD 26 and 52 weeks Changes in CSF biomarkers associated with AD
Exploratory Endpoints - Treatment Effects in Activities of Daily Living 13, 26, 39 and 52 weeks Changes from baseline in functioning in activities of daily living (ADL) as measured by the Alzheimer's Disease Cooperative Study - instrumental Activities of Daily Living (ADCS-iADL). The scale is used to assess functional decline in participants. The participants study partner is asked questions about the participants activities of daily living.
Exploratory Endpoints - Treatment Effects in Cognitive Impairment 26 and 52 Weeks. Change from baseline in Mini-mental status examination (MMSE). The rater will ask the participant a series of questions and ask the participants to perform some tasks. It used to assess cognitive impairment.
Exploratory Endpoints - Treatment Effects in Behavioral Symptoms and Functioning 13, 26, 39 and 52 weeks Changes from baseline in behavioral symptoms and functioning as measured by the Neuropsychiatric Inventory (NPI). The purpose of the NPI is to obtain information on the presence of psychopathology in patients with brain disorders.The participants caregiver is asked questions in an interview to evaluate the participants behaviour.
Endpoints for Treatment Effects on Volumes of Brain Structures 26 and 52 weeks Changes in the volumes of specified brain structures as measured by brain MRI
Exploratory Endpoints - Treatment Effects in Dementia Severity 13, 26, 39 and 52 weeks Changes from baseline in dementia severity as measured by the Clinical Dementia Rating Scale Sum of Boxes (CDR-SB). The CDR-SB is a semi structured interview with the participants caregiver, used to asses the severity of the symptoms of dementia.
Trial Locations
- Locations (3)
Neurodegenerative Disorders Research Pty Ltd
🇦🇺West Perth, Western Australia, Australia
Austin Health
🇦🇺Heidelberg, Victoria, Australia
Goulburn Valley Health
🇦🇺Shepparton, Victoria, Australia