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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT05332678
Registration number
NCT05332678
Ethics application status
Date submitted
25/03/2022
Date registered
18/04/2022
Date last updated
11/04/2023
Titles & IDs
Public title
SLS-005 (Trehalose Injection) in the Treatment of Alzheimer's Disease
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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)
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Secondary ID [1]
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SLS-005-207
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Universal Trial Number (UTN)
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Trial acronym
[STRIVE-AD]
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Alzheimer's Disease
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Condition category
Condition code
Neurological
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Alzheimer's disease
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Neurological
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Dementias
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Endpoints for Safety and Tolerability of Treatment
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Assessment method [1]
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Incidences of treatment-emergent Adverse Events and Serious Adverse Events (SAEs), including clinically significant laboratory and electrocardiogram (ECG) abnormalities
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Timepoint [1]
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over 52 week treatment period
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Primary outcome [2]
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Endpoints for Safety and Tolerability of Treatment
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Assessment method [2]
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Incidences of treatment-emergent early study and treatment discontinuations.
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Timepoint [2]
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52 weeks
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Secondary outcome [1]
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Endpoints for Treatment Effects on Imaging Biomarkers Associated with AD
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Assessment method [1]
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Changes in brain imaging biomarkers associated with AD
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Timepoint [1]
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26 and 52 weeks
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Secondary outcome [2]
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Endpoints for Treatment Effects on CSF Biomarkers Associated with AD
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Assessment method [2]
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Changes in CSF biomarkers associated with AD
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Timepoint [2]
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26 and 52 weeks
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Secondary outcome [3]
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Endpoints for Treatment Effects on Volumes of Brain Structures
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Assessment method [3]
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Changes in the volumes of specified brain structures as measured by brain MRI
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Timepoint [3]
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26 and 52 weeks
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Secondary outcome [4]
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Exploratory Endpoints - Treatment Effects in Cognitive Performance
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Assessment method [4]
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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
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Timepoint [4]
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13, 26, 39 and 52 weeks
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Secondary outcome [5]
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Exploratory Endpoints - Treatment Effects in Dementia Severity
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Assessment method [5]
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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.
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Timepoint [5]
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13, 26, 39 and 52 weeks
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Secondary outcome [6]
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Exploratory Endpoints - Treatment Effects in Activities of Daily Living
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Assessment method [6]
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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.
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Timepoint [6]
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13, 26, 39 and 52 weeks
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Secondary outcome [7]
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Exploratory Endpoints - Treatment Effects in Behavioral Symptoms and Functioning
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Assessment method [7]
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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.
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Timepoint [7]
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13, 26, 39 and 52 weeks
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Secondary outcome [8]
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Exploratory Endpoints - Treatment Effects in Cognitive Impairment
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Assessment method [8]
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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.
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Timepoint [8]
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26 and 52 Weeks.
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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.
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Minimum age
50
Years
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Maximum age
85
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Withdrawn
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
3/03/2023
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
10/04/2023
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Sample size
Target
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC,WA
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Recruitment hospital [1]
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Austin Health - Heidelberg
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Recruitment hospital [2]
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Goulburn Valley Health - Shepparton
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Recruitment hospital [3]
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Neurodegenerative Disorders Research Pty Ltd - West Perth
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Recruitment postcode(s) [1]
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3084 - Heidelberg
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Recruitment postcode(s) [2]
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3630 - Shepparton
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Recruitment postcode(s) [3]
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6005 - West Perth
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Seelos Therapeutics, Inc.
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Address
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Country
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT05332678
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05332678
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