SLS-005 (Trehalose Injection) in the Treatment of Alzheimer's Disease

NCT05332678 | Withdrawn Phase 2 DMC

• 1 other identifier: SLS-005-207
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 3

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.

Conditions

Alzheimer's Disease

Keywords

Trehalose; Phase II; Dementia; Australia; SLS-005; STRIVE-AD

Outcome Measures

Primary Outcomes (2)

• Endpoints for Safety and Tolerability of Treatment

  Incidences of treatment-emergent Adverse Events and Serious Adverse Events (SAEs), including clinically significant laboratory and electrocardiogram (ECG) abnormalities

  over 52 week treatment period

• Endpoints for Safety and Tolerability of Treatment

  Incidences of treatment-emergent early study and treatment discontinuations.

  52 weeks

Secondary Outcomes (8)

• Endpoints for Treatment Effects on Imaging Biomarkers Associated with AD

  26 and 52 weeks

• Endpoints for Treatment Effects on CSF Biomarkers Associated with AD

  26 and 52 weeks

• Endpoints for Treatment Effects on Volumes of Brain Structures

  26 and 52 weeks

• Exploratory Endpoints - Treatment Effects in Cognitive Performance

  13, 26, 39 and 52 weeks

• Exploratory Endpoints - Treatment Effects in Dementia Severity

  13, 26, 39 and 52 weeks

Study Arms (2)

SLS-005 - Once Weekly

EXPERIMENTAL

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.

Drug: SLS-005 - Once Weekly

SLS-005 - Twice Weekly

EXPERIMENTAL

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.

Drug: SLS-005 - Twice Weekly

Interventions

SLS-005 - Once Weekly DRUG

Please see Arm description.

Also known as: SLS-005

SLS-005 - Once Weekly

SLS-005 - Twice Weekly DRUG

Please see Arm description.

Also known as: SLS-005

SLS-005 - Twice Weekly

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have a study partner/caregiver who, in the Investigator's judgment, has frequent and sufficient face-to-face contact with the participant (approximately 10 hours per week or more) and consents to attend all study visits, assist in ensuring compliance with all study requirements and procedures, and provide input into assessments of cognitive performance and functioning in daily activities throughout the full duration of the participant's involvement in the study.
• Signed informed consent from:
• The participant or person responsible/guardian
• The participant's study partner/caregiver
• Men and women, 50 to 85 years (inclusive) of age.
• Gradual and progressive change in cognitive performance has been observed for ≥ 6 months not associated with a specific event or medical condition e.g., head trauma, stroke, cardiac arrest, cerebrovascular disease, epilepsy, alcohol abuse, etc.
• Capable of completing study assessments either alone or with assistance from the study partner.
• Mini-mental status examination (MMSE) score ≥ 16 and ≤ 27 at screening.
• Modified Hachinski Score ≤ 4 at screening.
• Body Mass Index (BMI) between 20 kg/m2 and 32 kg/m2 (inclusive)
• Clinical Dementia Rating (CDR) global score of 0.5, 1.0, or 2.0 at screening.
• Clinical Dementia Rating - Sum of Boxes (CDR-SB) score ≥ 0.5 at screening.
• Documentation of results for either CSF Aβ42, CSF Aβ42/Aβ40 ratio, or brain imaging with PET (amyloid or tau) that was consistent with a diagnosis of AD within 12 months of screening.
• Stable doses of all concomitant medications for at least 30 days prior to the baseline visit.
• For participants taking cholinesterase inhibitors and/or memantine, documentation of stable use for at least 12 weeks is required prior to screening.

You may not qualify if:

• Presence of a neurologic or neuropsychiatric condition or imaging finding associated with a neurologic or neuropsychiatric condition other than AD that can be associated with dementia or confound the evaluation of dementia, including but not limited to Parkinson's disease, Huntington's disease, frontotemporal dementia, cerebrovascular disease, (diseases related to or events associated with disruption of blood flow to the brain), seizure disorders, inflammatory or infectious disorders of the central nervous system, normal pressure hydrocephalus, traumatic brain injury, uncontrolled major depression, psychosis, bipolar disorder, and long-term sequelae of alcohol or substance abuse.
• History of stroke or transient ischemic attack (TIA) within 12 months of screening.
• Epileptic or epileptiform seizure within 12 months of screening.
• Current participation in another clinical trial or completed participation in an interventional trial less than 30 days prior to the screening visit (90 days for a biological treatment).
• Involvement in an Aβ or tau vaccination trial for AD unless known to have received only placebo.
• Current diagnosis and/or healthcare professional-recommended treatment (medication and/or diet) of diabetes mellitus type 1 or type 2.
• Hemoglobin A1c (HbA1c) ≥ 6.5% at the screening visit
• Prior treatment with SLS-005, any other IV trehalose formulation, or known hypersensitivity to trehalose.
• Is receiving aducanumab or any other immunotherapy for treatment of dementia including AD.
• Regular use (≥ 3 days per week) of prescribed or pharmacy-purchased opiates, opioids, or benzodiazepines.
• Pregnant or breastfeeding.
• History of alcohol or drug abuse within the last 2 years.
• Chronic liver disease including Hepatitis B; Hepatitis C unless successful curative treatment is documented; human immunodeficiency virus (HIV) infection.
• Prior history of drug-induced liver injury (DILI) and/or laboratory results at screening that indicate inadequate liver function (e.g., alanine aminotransferase \[ALT\], aspartate aminotransferase \[AST\], gamma-glutamyl transferase \[GGT\] \> 2 times the upper limit of normal \[x ULN\] and/or total bilirubin level \> 2 x ULN).
• Laboratory results at screening that indicate inadequate renal function (e.g., estimated creatinine clearance of \< 60 mL/min calculated by the Cockcroft and Gault formula).

Sponsors & Collaborators

• Seelos Therapeutics, Inc.: lead

Study Sites (3)

Austin Health

Heidelberg, Victoria, 3084, Australia

Location

Goulburn Valley Health

Shepparton, Victoria, 3630, Australia

Location

Neurodegenerative Disorders Research Pty Ltd

West Perth, Western Australia, 6005, Australia

Location

MeSH Terms

Conditions

Alzheimer Disease; Dementia

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2022
• First Posted: April 18, 2022
• Study Start: March 3, 2023
• Primary Completion: April 10, 2023
• Study Completion: April 10, 2023
• Last Updated: April 11, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

AU (3)