| Eligibility |
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.
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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