- Study Director: Adam Boxer, MD, PhD
- Recruiting? Active, not recruiting
- 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 Identifier: NCT03277573
- Conditions Studied: Mild to moderate Alzheimer’s disease
- Intervention: Salsalate and placebo control. 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.
- Phase: Phase 1b
Purpose of the Study
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.
Eligibility
Inclusion Criteria: 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.
Exclusion Criteria: Participants must not have a severe or unstable medical condition that, in the opinion of the investigator or sponsor, would interfere with the patient’s ability to complete the study assessments or would require the equivalent of institutional or hospital care. Participants also should not have a history of vascular disease affecting the brain or a history of severe brain trauma. Participants must also not have a history of significant cardiovascular, hematologic, renal, hepatic, or autoimmune disease. Any history of peptic ulcer disease, GI bleeding, or asthma, urticarial or allergic-type reactions after taking NSAIDs or aspirin is also excluded. Participants with chronic use of other NSAIDs or salicylates for any reason, except for daily baby aspirin, will also be excluded. Participants must not be currently enrolled in another clinical trial.
What to Expect
Testing: Neurological and physical examinations, MRIs, one PET scan, at least two lumbar punctures, cognitive testing and neuropsychiatric assessments, EKGs, telephone calls, blood and urine specimen collection, and vital signs
The Frequency of Visits:
- Screening phase: 2–3 visits within four weeks of the first dose
- Dose administration in the placebo-controlled period: 12 months
- Follow up visits after dose administration period: 4 weeks after the last dose
Materials Needed Before Evaluation: Meets NIAAA core clinical criteria for probable AD dementia
Costs: No costs will be charged for any of the study procedures. Parking will be validated at UCSF public garages for all study visits, and participants will be reimbursed up to $50 for each scheduled visit to help defray any incidental expenses incurred in the course of participating in this study.