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Find more clinical trials

Tau Screening in Early Alzheimer's Disease

Start: March 8, 2018
End: November 2018
Enrollment: 250

What Is This Study About?

This prescreening study will test for tau levels in older adults who have early Alzheimers disease and may be eligible for therapeutic trials that require tau imaging.

Do I Qualify To Participate in This Study?

Minimum Age: 60 Years

Maximum Age: 85 Years

Must have:

  • Gradual and progressive change in memory over 6 months or more
  • Mini-Mental State Examination score of 20 to 27
  • Cogstate Brief Battery learning/working memory score of 80 to 90 if available at study site
  • Study partner

Must NOT have:

  • Low literacy, vision, or hearing abilities that could interfere with psychometric testing
  • Pregnant or breastfeeding; must agree to avoid becoming pregnant for 24 hours after injection
  • Neurological disease other than Alzheimer's affecting the central nervous system, including other dementias, serious brain infection, Parkinson's disease, multiple concussions, epilepsy, or recurrent seizures (except febrile childhood seizures)
  • History of schizophrenia or other chronic psychosis or current psychiatric diagnosis that could interfere with study or results
  • Serious or unstable illness including, heart, liver, kidney, digestive, respiratory, endocrinologic, immunologic, blood disease, or other condition that could interfere with study
  • Life expectancy of less than 2 years
  • Cancer within the last 5 years (except non-metastatic basal and/or squamous cell skin cancer, in situ cervical cancer, non-progressive prostate cancer, or other cancers with low risk of recurrence or spread)
  • History (suspected or confirmed) of hepatitis B or hepatitis C
  • Serious risk for suicide
  • History of alcohol or drug disorder (except tobacco use disorder) in past 2 years
  • History of multiple or severe drug allergies or severe post-treatment hypersensitivity reactions, including erythema multiforme major, linear immunoglobulin A dermatosis, toxic epidermal necrolysis, and/or exfoliative dermatitis
  • Known positive findings for human immunodeficiency virus antibodies
  • Evidence on magnetic resonance imaging (MRI) that could suggest another cause of dementia or a finding that may impact participation
  • Inability to undergo MRI, including claustrophobia, metal implants, or a cardiac pacemaker
  • Abnormality at screening in physical or neurological exam, or laboratory or other tests that could impact participation
  • Use of drugs known to significantly prolong the QT interval within 14 days or 5 half-lives (whichever is longer) of a scheduled screening or scan, or history of risk factors for torsade du pointes
  • Electrocardiography-corrected QT interval measurement more than 450 milliseconds for men or 470 milliseconds for women
  • Poor venous access
  • Inability to undergo positron emission tomography (PET) scan or hypersensitivity to flortaucipir F 18 or any of its components
  • Present or planned exposure to ionizing radiation that would result in cumulative exposure above recommended limits
  • Participation in the last 30 days in a clinical trial not compatible with this study
  • Prohibited participants: investigator site personnel, their immediate families, Eli Lilly employees, and employees of third-party organizations that require exclusion
  • Use of acetylcholinesterase inhibitorsrivastigmine, donepezil, or galantamineand/or memantine for less than 1 month; if recently discontinued use, must be for at least 1 month
  • Changes in medications that could affect cognition should be stable for at least 1 month (does not apply to medicines used for a limited time, such as antibiotics)
  • Use of active immunization agents for the treatment of Alzheimer's disease
  • Allergies to monoclonal antibodies, diphenhydramine, epinephrine, or methylprednisolone; or to LY3303560 or any related compounds or components of the formulation
  • History of significant atopy (genetic disposition to develop an allergic reaction)
  • Receiving immunoglobulin replacement therapy (also known as gamma globulin or intravenous immunoglobulin)

If I Qualify, Who Do I Contact?

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

Who Is the General Study Contact?

For more information about this study or study sites, contact Avid Clinical Operations at clinicaloperations@avidrp.com or 215-298-0700.

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: Avid Radiopharmaceuticals

Source: ClinicalTrials.gov ID: NCT03467477

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