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?
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
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?
Source:
ClinicalTrials.gov ID:
NCT03277573