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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05332678




Registration number
NCT05332678
Ethics application status
Date submitted
25/03/2022
Date registered
18/04/2022

Titles & IDs
Public title
SLS-005 (Trehalose Injection) in the Treatment of Alzheimer's Disease
Scientific title
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) in Participants With Alzheimer's Disease (AD)
Secondary ID [1] 0 0
SLS-005-207
Universal Trial Number (UTN)
Trial acronym
[STRIVE-AD]
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Alzheimer's Disease 0 0
Condition category
Condition code
Neurological 0 0 0 0
Alzheimer's disease
Neurological 0 0 0 0
Dementias

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - SLS-005 - Once Weekly
Treatment: Drugs - SLS-005 - Twice Weekly

Experimental: 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.

Experimental: 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.


Treatment: Drugs: SLS-005 - Once Weekly
Please see Arm description.

Treatment: Drugs: SLS-005 - Twice Weekly
Please see Arm description.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Endpoints for Safety and Tolerability of Treatment
Timepoint [1] 0 0
over 52 week treatment period
Primary outcome [2] 0 0
Endpoints for Safety and Tolerability of Treatment
Timepoint [2] 0 0
52 weeks
Secondary outcome [1] 0 0
Endpoints for Treatment Effects on Imaging Biomarkers Associated with AD
Timepoint [1] 0 0
26 and 52 weeks
Secondary outcome [2] 0 0
Endpoints for Treatment Effects on CSF Biomarkers Associated with AD
Timepoint [2] 0 0
26 and 52 weeks
Secondary outcome [3] 0 0
Endpoints for Treatment Effects on Volumes of Brain Structures
Timepoint [3] 0 0
26 and 52 weeks
Secondary outcome [4] 0 0
Exploratory Endpoints - Treatment Effects in Cognitive Performance
Timepoint [4] 0 0
13, 26, 39 and 52 weeks
Secondary outcome [5] 0 0
Exploratory Endpoints - Treatment Effects in Dementia Severity
Timepoint [5] 0 0
13, 26, 39 and 52 weeks
Secondary outcome [6] 0 0
Exploratory Endpoints - Treatment Effects in Activities of Daily Living
Timepoint [6] 0 0
13, 26, 39 and 52 weeks
Secondary outcome [7] 0 0
Exploratory Endpoints - Treatment Effects in Behavioral Symptoms and Functioning
Timepoint [7] 0 0
13, 26, 39 and 52 weeks
Secondary outcome [8] 0 0
Exploratory Endpoints - Treatment Effects in Cognitive Impairment
Timepoint [8] 0 0
26 and 52 Weeks.

Eligibility
Key inclusion criteria
Inclusion Criteria

1. 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.
2. Signed informed consent from:

1. The participant or person responsible/guardian
2. The participant's study partner/caregiver
3. Men and women, 50 to 85 years (inclusive) of age.
4. 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.
5. Capable of completing study assessments either alone or with assistance from the study partner.
6. Mini-mental status examination (MMSE) score = 16 and = 27 at screening.
7. Modified Hachinski Score = 4 at screening.
8. Body Mass Index (BMI) between 20 kg/m2 and 32 kg/m2 (inclusive)
9. Clinical Dementia Rating (CDR) global score of 0.5, 1.0, or 2.0 at screening.
10. Clinical Dementia Rating - Sum of Boxes (CDR-SB) score = 0.5 at screening.
11. Documentation of results for either CSF Aß42, CSF Aß42/Aß40 ratio, or brain imaging with PET (amyloid or tau) that was consistent with a diagnosis of AD within 12 months of screening.
12. Stable doses of all concomitant medications for at least 30 days prior to the baseline visit.
13. For participants taking cholinesterase inhibitors and/or memantine, documentation of stable use for at least 12 weeks is required prior to screening.
14. Negative serum beta-human chorionic gonadotropin (ß-hCG) pregnancy result at the screening visit for female participants of childbearing potential.
15. Willingness to comply with sexual abstinence or contraception guidelines of this study.
16. Willingness and ability to complete all study procedures, including brain magnetic resonance imaging (MRI), lumbar puncture, clinical genotyping, and brain positron emission tomography (PET).
17. Participant and study partner/caregiver must be fluent in the English language for both reading and speaking.
18. Participant and study partner/caregiver must be fully vaccinated as per local regulations for COVID-19 at least 2 weeks prior to screening.
Minimum age
50 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria

1. 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.
2. History of stroke or transient ischemic attack (TIA) within 12 months of screening.
3. Epileptic or epileptiform seizure within 12 months of screening.
4. 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).
5. Involvement in an Aß or tau vaccination trial for AD unless known to have received only placebo.
6. Current diagnosis and/or healthcare professional-recommended treatment (medication and/or diet) of diabetes mellitus type 1 or type 2.
7. Hemoglobin A1c (HbA1c) = 6.5% at the screening visit
8. Prior treatment with SLS-005, any other IV trehalose formulation, or known hypersensitivity to trehalose.
9. Is receiving aducanumab or any other immunotherapy for treatment of dementia including AD.
10. Regular use (= 3 days per week) of prescribed or pharmacy-purchased opiates, opioids, or benzodiazepines.
11. Pregnant or breastfeeding.
12. History of alcohol or drug abuse within the last 2 years.
13. Chronic liver disease including Hepatitis B; Hepatitis C unless successful curative treatment is documented; human immunodeficiency virus (HIV) infection.
14. 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).
15. 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).
16. Recent history of heart failure or unexplained edema or any current cardiovascular disease or abnormality on 12-lead ECG at screening that, in the investigator's opinion, is clinically significant and could be a potential safety risk to the participant, including risk factors for stroke (e.g., atrial fibrillation, cardiomyopathy).
17. History of cancer (currently active or in remission) within 5 years prior to screening, excluding treated basal or squamous skin cancer, or stable prostate cancer.
18. Lack of reliable venous access for the weekly administration of study drug.
19. Contraindications to the lumbar puncture (LP) procedure such as prior lumbosacral spine surgery, severe degenerative joint disease or deformity of the spine, platelet count < 100,000, use of an anticoagulant (e.g., warfarin), or history of a bleeding disorder.
20. Any current psychiatric or neurological disorder other than AD that, in the investigator's opinion, may interfere with the participant's ability to provide informed consent or appropriately complete the study's safety or efficacy assessments.
21. Significant suicide risk as indicated by a "yes" response to #4 or #5 under Suicidal Ideation or any "yes" response under Suicidal Behavior on the Columbia Suicide Severity Rating Scale (C-SSRS) during the screening visit.
22. Any other medical condition or abnormal finding during screening that, in the investigator's opinion, could confound collection or interpretation of safety or efficacy data or be a potential safety risk to the participant.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Withdrawn
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
3/03/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
10/04/2023
Sample size
Target
Accrual to date
Final
0
Recruitment in Australia
Recruitment state(s)
VIC,WA
Recruitment hospital [1] 0 0
Austin Health - Heidelberg
Recruitment hospital [2] 0 0
Goulburn Valley Health - Shepparton
Recruitment hospital [3] 0 0
Neurodegenerative Disorders Research Pty Ltd - West Perth
Recruitment postcode(s) [1] 0 0
3084 - Heidelberg
Recruitment postcode(s) [2] 0 0
3630 - Shepparton
Recruitment postcode(s) [3] 0 0
6005 - West Perth

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Seelos Therapeutics, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05332678