Alzheimer's DiseasePhase 2[STRIVE-AD]NCT05332678
SLS-005 (Trehalose Injection) in the Treatment of Alzheimer's Disease
A Phase 2 study testing SLS-005 - Once Weekly and SLS-005 - Twice Weekly in people with Alzheimer's Disease, run by Seelos Therapeutics, Inc. at 3 sites in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- SLS-005 - Once Weekly and SLS-005 - Twice Weekly
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 3 sitesAustralia
- Study dates
- 3 Mar 2023to 10 Apr 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
- Negative serum beta-human chorionic gonadotropin (ß-hCG) pregnancy result at the screening visit for female participants of childbearing potential.
- Willingness to comply with sexual abstinence or contraception guidelines of this study.
- Willingness and ability to complete all study procedures, including brain magnetic resonance imaging (MRI), lumbar puncture, clinical genotyping, and brain positron emission tomography (PET).
- Participant and study partner/caregiver must be fluent in the English language for both reading and speaking.
- Participant and study partner/caregiver must be fully vaccinated as per local regulations for COVID-19 at least 2 weeks prior to screening.
Who cannot join
- 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.
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- 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).
- 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).
- 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.
- Lack of reliable venous access for the weekly administration of study drug.
- 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.
- 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.
- 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.
- 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.
Trial locations and contacts
3 sites in 1 country.
Australia3 sites
Austin Health
Heidelberg, Victoria, 3084
Goulburn Valley Health
Shepparton, Victoria, 3630
Neurodegenerative Disorders Research Pty Ltd
West Perth, Western Australia, 6005
About this study
Official 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)
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.
Read the 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.
- Conditions
- Alzheimer's Disease
- Being tested
- SLS-005 - Once Weekly, SLS-005 - Twice Weekly
- Keywords
- Trehalose, Phase II, Dementia, Australia, SLS-005, STRIVE-AD
- Medical subject headings
- Alzheimer Disease, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SLS-005 - Once WeeklyDrug
Also called SLS-005
Please see Arm description.
SLS-005 - Twice WeeklyDrug
Also called SLS-005
Please see Arm description.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: SLS-005 - Twice Weekly |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: over 52 week treatment period
Endpoints for Safety and Tolerability of Treatment
Incidences of treatment-emergent early study and treatment discontinuations.
Measured: 52 weeks
Secondary outcomes (8)
Endpoints for Treatment Effects on Imaging Biomarkers Associated with AD
Changes in brain imaging biomarkers associated with AD
Measured: 26 and 52 weeks
Endpoints for Treatment Effects on CSF Biomarkers Associated with AD
Changes in CSF biomarkers associated with AD
Measured: 26 and 52 weeks
Endpoints for Treatment Effects on Volumes of Brain Structures
Changes in the volumes of specified brain structures as measured by brain MRI
Measured: 26 and 52 weeks
Exploratory Endpoints - Treatment Effects in Cognitive Performance
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
Measured: 13, 26, 39 and 52 weeks
Exploratory Endpoints - Treatment Effects in Dementia Severity
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.
Measured: 13, 26, 39 and 52 weeks
Exploratory Endpoints - Treatment Effects in Activities of Daily Living
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.
Measured: 13, 26, 39 and 52 weeks
Exploratory Endpoints - Treatment Effects in Behavioral Symptoms and Functioning
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.
Measured: 13, 26, 39 and 52 weeks
Exploratory Endpoints - Treatment Effects in Cognitive Impairment
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.
Measured: 26 and 52 Weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2022
- Study start3 Mar 2023
- Primary completion10 Apr 2023
- Study completion10 Apr 2023
Why it stopped: Sponsor Decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seelos Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05332678
- Sponsor's protocol ID
- SLS-005-207
- Acronym
- [STRIVE-AD]
- Status last verified
- Apr 2023
- First submitted
- 25 Mar 2022
- Last updated
- 11 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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)
- ClinicalTrials.gov ID
- NCT05332678
- Acronym / sponsor ID
- [STRIVE-AD] / SLS-005-207
- Conditions
- Alzheimer's Disease
- Keywords
- Trehalose, Phase II, Dementia, Australia, SLS-005, STRIVE-AD
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Sponsor Decision
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Seelos Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 3 Mar 2023 (actual)
- Primary completion
- 10 Apr 2023 (actual)
- Study completion
- 10 Apr 2023 (actual)
- First posted
- 18 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SLS-005 - Once Weekly | Experimental | Drug: SLS-005 - Once WeeklySLS-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. |
| SLS-005 - Twice Weekly | Experimental | Drug: SLS-005 - Twice WeeklySLS-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. |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- 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:
- 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.
Key exclusion criteria (22 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SLS-005 - Once WeeklyAlso: SLS-005Please see Arm description. | Drug | SLS-005 - Once Weekly |
| SLS-005 - Twice WeeklyAlso: SLS-005Please see Arm description. | Drug | SLS-005 - Twice Weekly |
Primary outcome
Endpoints for Safety and Tolerability of Treatment
Time frame: over 52 week treatment period
Incidences of treatment-emergent Adverse Events and Serious Adverse Events (SAEs), including clinically significant laboratory and electrocardiogram (ECG) abnormalities
Endpoints for Safety and Tolerability of Treatment
Time frame: 52 weeks
Incidences of treatment-emergent early study and treatment discontinuations.
8 secondary outcomes
Endpoints for Treatment Effects on Imaging Biomarkers Associated with AD
Time frame: 26 and 52 weeks
Endpoints for Treatment Effects on CSF Biomarkers Associated with AD
Time frame: 26 and 52 weeks
Endpoints for Treatment Effects on Volumes of Brain Structures
Time frame: 26 and 52 weeks
Exploratory Endpoints - Treatment Effects in Cognitive Performance
Time frame: 13, 26, 39 and 52 weeks
Exploratory Endpoints - Treatment Effects in Dementia Severity
Time frame: 13, 26, 39 and 52 weeks
Exploratory Endpoints - Treatment Effects in Activities of Daily Living
Time frame: 13, 26, 39 and 52 weeks
Exploratory Endpoints - Treatment Effects in Behavioral Symptoms and Functioning
Time frame: 13, 26, 39 and 52 weeks
Exploratory Endpoints - Treatment Effects in Cognitive Impairment
Time frame: 26 and 52 Weeks.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SLS-005 - Once Weekly and SLS-005 - Twice Weekly in people with Alzheimer's Disease, run by Seelos Therapeutics, Inc. at 3 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 11 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Endpoints for Safety and Tolerability of Treatment (time frame: over 52 week treatment period). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2023.