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Find more clinical trials

Varoglutamstat for Early-Stage Alzheimer's Disease

Start: November 15, 2021
End: November 2023
Enrollment: 414

What Is This Study About?

This Phase 2 study will test the safety and effectiveness of varoglutamstat to reduce amyloid deposits in older adults with early-stage Alzheimer's disease. In the first phase of this study, participants will be randomly assigned to receive one of three dosage levels of the study drug or a placebo by tablet twice a day for six months. In the second phase, participants will take the highest safe dose identified in the first phase and researchers will assess the longer term effects of the study drug up to 72 weeks. At the end of each study phase, researchers will measure any changes in brain activity, and cognitive and daily functioning. They will also collect blood and cerebral spinal fluid samples to analyze drug absorption and any changes in the levels of amyloid protein. Throughout the study, participants will be monitored for any adverse health events.

Do I Qualify To Participate in This Study?

Minimum Age: 50 Years

Maximum Age: 89 Years

Must have:

  • Diagnosis of mild cognitive impairment or early-stage Alzheimer's disease
  • Mini-Mental State Examination score of 20 to 30 at study screening
  • Montreal Cognitive Assessment score < 26 at screening
  • Clinical Dementia Rating global score of 0.5 or 1 with memory score of > 0.5 at study screening
  • Presence of Alzheimer's disease proteins in cerebrospinal fluid
  • MRI brain scan within six months of study screening consistent with a diagnosis of Alzheimer's disease
  • Study partner who has frequent interaction with the participant (> 3-4 times per week) and who is available to attend all clinic visits and can assist the participant with study procedures

Must NOT have:

  • Any significant neurodegenerative disease, other than Alzheimer's (e.g., Parkinson's disease, Huntington's disease, vascular dementia, Creutzfeldt-Jakob disease, Lewy Body dementia, progressive supranuclear palsy, AIDS, or normal pressure hydrocephalus)
  • Severe liver disease
  • Participation in another clinical trial for an experimental drug with at least one dose of study drug taken 90 days prior to the start of the study; confirmed use of a placebo is acceptable
  • History of significant medical or psychiatric conditions that could interfere with study participation including:
    • Moderate or severe skin reactions to medications, or current moderate to severe skin disease
    • Major depression within six months prior to the study screening
    • Schizophrenia
    • Uncontrolled bipolar disorder within five years prior to the study screening
    • Seizures within two years prior to the study screening
  • Any condition that could make having the following study procedures unsafe:
    • Lumbar puncture (e.g., skin infection on lower back, trauma to lower back, bleeding disorder or taking blood thinners)
    • MRI brain scan (e.g., metal shrapnel, heart pacemaker, severe claustrophobia)

If I Qualify, Who Do I Contact?

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

Study Contact
Archana Balasubramanian
Tanja Wassmann

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?

Arizona
Barrow Neurological Institute
Phoenix, AZ 85013
Recruiting
Banner Sun Health Research Institute
Sun City, AZ 85351
Recruiting
California
The Neuron Clinic
Chula Vista, CA 91910
Recruiting
University of California
Irvine, CA 92868
Recruiting
UCSD Alzheimer's Disease Research Center
La Jolla, CA 92037
Recruiting
Cedars-Sinai Center
Los Angeles, CA 90048
Recruiting
PCND Neurology
Poway, CA 92064
Recruiting
District of Columbia
Georgetown University Medical Center
Washington, DC 20057
Recruiting
Florida
USF Health Byrd Alzheimer's Center and Research Institute
Tampa, FL 33613
Recruiting
Georgia
Emory University
Atlanta, GA 30329
Recruiting
Illinois
Northwestern University Feinberg School of Medicine
Chicago, IL 60611
Recruiting
Iowa
The University of Iowa Carver College of Medicine
Iowa City, IA 52242
Recruiting
Kentucky
The University of Kentucky Sanders-Brown Center on Aging
Lexington, KY 40504
Recruiting
Maine
Northern Light Acadia Hospital
Bangor, ME 04401
Recruiting
New York
NYU Langone Health Tisch Hospital
New York, NY 10016
Recruiting
SUNY Upstate Medical University
Syracuse, NY 13210
Recruiting
Ohio
Ohio State University
Columbus, OH 43210
Recruiting
Oregon
OHSU Neurology Clinic
Portland, OR 97239
Recruiting
Pennsylvania
Abington Neurological Associates
Abington, PA 19001
Recruiting
Rhode Island
Rhode Island Hospital
Providence, RI 02903
Recruiting
South Carolina
Lowcountry Center for Veterans Research (LCVR)
Charleston, SC 29403
Recruiting
Texas
UT Health San Antonio
San Antonio, TX 78229
Recruiting

Who Sponsors This Study?

Lead: Vivoryon Therapeutics N.V.

Collaborator Sponsor

  • Alzheimer's Disease Cooperative Study (ADCS)
  • National Institute on Aging (NIA)

Source: ClinicalTrials.gov ID: NCT03919162

alzheimers.gov

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