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Find more clinical trials

Salsalate for Mild to Moderate Alzheimer's Disease

Start: July 21, 2017
End: December 2021
Enrollment: 40

What Is This Study About?

The purpose of the study is to test the safety and tolerability of twice daily salsalate, a nonsteroidal anti-inflammatory drug (NSAID), in adults with mild to moderate Alzheimer's disease.

Do I Qualify To Participate in This Study?

Minimum Age: 50 Years

Maximum Age: 85 Years

Must have:

  • Probable Alzheimers disease
  • Magnetic resonance imaging (MRI) consistent with Alzheimers
  • Positron emission tomography (PET) scan showing elevated amyloid (previous amyloid-beta/tau level positivity may also be used)
  • Modified Hachinski Ischemic Score less than or equal to 4; Mini-Mental State Examination score of 14 to 30
  • Alzheimers medications allowed if stable for 2 months
  • Other allowed medications must be stable for 30 days
  • Study partner who spends at least 5 hours per week with participant and will come to study visits
  • Agrees to lumbar puncture and cerebrospinal fluid collection
  • Males and females with child-bearing potential must abstain from sex or use contraception for study duration and 30 days after last dose

Must NOT have:

  • Medical condition other than Alzheimers that could account for cognitive deficits, such as active seizure disorder, stroke, or vascular dementia
  • Significant heart, blood, kidney, or liver disease
  • Systolic blood pressure over 180 mmHg or diastolic blood pressure over 100 mmHg
  • History of peptic ulcer disease or gastrointestinal bleeding
  • History of asthma, hives, or allergic reactions after taking NSAIDs or aspirin
  • History of aspirin triad (aspirin allergy, nasal polyps, and asthma)
  • History of significant autoimmune disorders
  • History of major psychiatric illness or major depression
  • Significant findings at screening that could pose a safety risk or interfere with study data
  • Significant bacterial or fungal infection within past 4 weeks or current significant viral infection, including chicken pox, flu, or flu symptoms
  • Major surgery within past 4 weeks
  • Inability to undergo MRI or lumbar puncture, including use of anti-coagulants such as warfarin (Coumadin , Jantoven )
  • Chronic use of NSAIDs or salicylates, including ibuprofen, naproxen, and aspirin except for daily baby aspirin (81 mg) if stable for 30 days
  • Chronic use of oral corticosteroids or other immunosuppressants
  • Participation in another Alzheimers trial within past 3 months or treatment with an investigational drug within 30 days
  • Pregnant or lactating
  • Cancer within past 5 years, except for non-metastatic skin or prostate cancer

If I Qualify, Who Do I Contact?

Contact study personnel listed either under the general study contact or the location nearest you.

Need Help?

Contact NIA’s Alzheimer’s and related Dementias Education and Referral (ADEAR) Center at 800-438-4380 or email ADEAR.

Where Is This Study Located?

Who Sponsors This Study?

Lead: Adam Boxer

Source: ClinicalTrials.gov ID: NCT03277573

alzheimers.gov

An official website of the U.S. government, managed by the National Institute on Aging at the National Institutes of Health