Salsalate in Patients Mild to Moderate Alzheimer's Disease (SAL-AD)
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|ClinicalTrials.gov Identifier: NCT03277573|
Recruitment Status : Active, not recruiting
First Posted : September 11, 2017
Last Update Posted : April 14, 2020
|Condition or disease||Intervention/treatment||Phase|
|Alzheimer Disease||Drug: Salsalate Drug: Placebo||Phase 1|
This is a Phase 1b, 12-month, randomized, double-blind, placebo-controlled study of the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of salsalate in patients with mild to moderate AD. Approximately 40 subjects will be randomized 1:1 to placebo or active. All study drugs will be administered orally bid [two placebo tablets bid or two 750 mg salsalate tablets bid (for a total daily dose of 3,000 mg)] for 12 months.
This study will test the effects of Salsalate on cerebrospinal fluid (CSF) proteins, brain magnetic resonance imaging (MRI), and cognitive (thinking and memory) tests in subjects with mild to moderate AD. This study uses placebo which looks like the experimental drug but does not have any active drug in it.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Randomized, Double-Blind, Placebo-Controlled|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Masking Description:||Double-Blind study. Only investigational pharmacist will be unblinded.|
|Official Title:||A Phase 1b, 12-Month, Randomized, Double-Blind, Placebo-Controlled Study of the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of Salsalate in Patients With Mild to Moderate Alzheimer's Disease|
|Actual Study Start Date :||July 21, 2017|
|Estimated Primary Completion Date :||December 21, 2020|
|Estimated Study Completion Date :||July 21, 2021|
Drug: Salsalate 2 tablets twice daily (3,000 mg total daily) by mouth for 12 months
Salsalate is a non-acetylated dimer of salicylic acid, and is classified as a non-steroidal anti-inflammatory drug (NSAID). Salsalate has been commercially available in the US as a prescription drug for the relief of the signs and symptoms of rheumatoid arthritis, osteoarthritis, and related rheumatic disorder for decades.
Placebo Comparator: Placebo
Drug: Placebo 2 tablets twice daily by mouth for 12 months
- Incidence of Treatment-Emergent Adverse Events [ Time Frame: 12 months ]Assess adverse events during 12 months administration of Salsalate or Placebo
- Changes in Pharmacokinetic properties of Salsalate in Plasma and Cerebrospinal Fluid [ Time Frame: 6; 11.5 months ]Measure steady-state plasma and cerebrosinal fluid concentrations of salsalate and its metabolites.
- Changes in Pharmacodynamic properties of Salsalate in Cerebrospinal Fluid [ Time Frame: 6; 11.5 months ]Measure CSF concentrations of total tau, phosphorylated tau, and neurofilament light chain
- Change in brain volume on brain MRI [ Time Frame: 6; 12 months ]Measure of global and regional volumes of interest (such as hippocampus)
- Change in structural and functional connectivity on brain MRI [ Time Frame: 6; 12 months ]Connectivity between brain regions measured using diffusion tensor MRI and resting state functional MRI
- Change in Cerebrospinal Fluid Biomarkers of phosphorylated tau [ Time Frame: 6; 11.5 months ]Measure CSF concentrations of phosphorylated tau protein (p-tau) pg/mL
- Change in Cerebrospinal Fluid Biomarkers of neurofilament light chain [ Time Frame: 6; 11.5 months ]Measure CSF concentrations of neurofilament light chain protein (NfL) pg/ml
- Change in Cerebrospinal Fluid Biomarkers of total tau [ Time Frame: 6; 11.5 months ]Measure CSF concentrations of total tau protein (t-tau) pg/mL
- Change in Cerebrospinal Fluid Biomarkers of beta amyloid 1-42 [ Time Frame: 6; 11.5 months ]Measure CSF concentrations of beta amyloid protein (Abeta1-42) pg/mL
- Change in Alzheimer's Disease Assessment Scale-cognitive scale [ Time Frame: 6;12 months ]Measure changes using the Alzheimer's Disease Assessment Scale-cognitive (ADAS-cog) which evaluates cognitive dysfunctions
- Change in Mini Mental State Examination [ Time Frame: 6;12 months ]Measure changes using the Mini Mental State Exam (MMSE) which evaluates cognitive function.
- Change in Alzheimer's disease Clinical Activities of Daily Living Scale [ Time Frame: 6;12 months ]Measure changes in function, and in particular the degree of disability using the Alzheimer's disease Clinical Activities of Daily Living scale (ADCS-ADL)
- Change in Clinical Dementia Rating Scale (CDR-SB) [ Time Frame: 6;12 months ]Measure change in dementia status using the Clinical Dementia Rating scale (CDR-SB)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03277573
|United States, California|
|University of California, San Diego|
|San Diego, California, United States, 92093|
|University of California, San Francisco|
|San Francisco, California, United States, 94158|
|Principal Investigator:||Adam Boxer, MD, PhD||UCSF Memory and Aging Center|