Alzheimer’s Disease Trial of Salsalate (SAL-AD)

Official Study 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.

ClinicalTrials.gov ID: NCT03277573.

The purpose of this study is to evaluate the safety and tolerability of Salsalate in comparison to placebo in patients with prodromal to mild Alzheimer’s disease. Salsalate has been marketed for decades in the US as a prescription drug for the relief of the signs and symptoms of rheumatoid arthritis, osteoarthritis, and related rheumatic disorders, but this is the first time Salsalate will be studied in people with Alzheimer’s disease.

Eligibility

Participants must be between 50–85 years old, meet the criteria for probable Alzheimer’s disease and have a reliable study partner who can accurately report the participant’s behavior and is able to accompany them to all study visits. Participants may take symptomatic Alzheimer’s disease medications but must be on stable doses of these medications for two months. Other medications permitted on the study are allowed as long as the dose is stable for 30 days prior to the initial screening. Participants must be willing and able to have MRIs throughout the course of the study, at least 2 lumbar punctures, and a florbetapir PET scan consistent with the presence of amyloid pathology at the screening. Participants must also have a Mini Mental State Examination (MMSE) score between 14–30, inclusive, at the time of screening. Males and all women of child-bearing potential must agree to abstain from sex or use an adequate method of contraception for the duration of the study and for 30 days after the last dose of the study drug.

Available Data

During the unblinding process, a minimal clinical dataset containing age range, sex at birth, Clinical Dementia Rating Scale Sum of Boxes (CDR-SB), and Mini Mental State Examination (MMSE), will be distributed.

All biospecimen requests undergo a formal review by the SAL-AD Biospecimens Committee. Reviews are scheduled in a quarterly fashion, according to the following schedule:

Available Biospecimens

Plasma, Serum, and DNA from a subset of participants (only those that did not screen-failed, n=40) collected during their Baseline Visit. Placebo and treated groups will not be disclosed at this time.

Price Structure
• Manual of Procedures