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Find more clinical trials

T3D-959 for Mild to Moderate Alzheimer's Disease

Start: July 2015
End: June 2016
Enrollment: 36

What Is This Study About?

This study will assess the effects of the experimental drug T3D-959 in people with mild to moderate Alzheimer's disease. Changes in cognition, glucose metabolism in the brain, blood oxygen levels, and brain connectivity will be evaluated.

Do I Qualify To Participate in This Study?

Minimum Age: 50 Years

Maximum Age: 90 Years

Must have:

  • Diagnosis of mild to moderate Alzheimer's disease 
  • Mini-Mental State Examination score of 14-26; Clinical Dementia Rating of 0.5 to 2.0; Modified Hachinski score of less than or equal to 4
  • Washout of psychoactive medications (other than antidepressants) at least 4 weeks before first testing
  • On stable dose of permitted medications for 4-12 weeks before first testing
  • Seeing and hearing ability adequate for neuropsychological testing
  • Caregiver to supervise taking medications

Must NOT have:

  • Diagnosis of diabetes, including use of diabetes medications, fasting plasma glucose level of >126 mg/dl, or hemoglobin A1c of >6.5 percent
  • Unable to participate in FDG-PET or MRI brain scan
  • Diagnosis of significant neurological/psychiatric disease other than Alzheimer's disease
  • History of moderate or severe congestive heart failure; cardiovascular event within the past 6 months
  • Pregnant or lactating
  • ALT and/or AST levels that are twice the upper limit of normal; bilirubin levels that exceed 2 mg/dL; serum creatinine >1.5 mg/dL in men or >1.4 mg/dL in women
  • Current or past severe or unstable medical or psychiatric disorder requiring treatment that may make the subject unlikely to complete the study
  • Prohibited medications: fluvoxamine, warfarin, certain highly protein-bound medications
  • Cancer within the last 5 years, other than nonmelanoma skin cancer; stable, nonprogressive prostate cancer not requiring treatment, or in situ cervical cancer
  • Known history of HIV, hepatitis B, or hepatitis C
  • Blood pressure greater than 160/100 mmHg
  • Known or suspected intolerance or hypersensitivity to the study drug, closely related compounds, or any of their ingredients
  • History of substance abuse or dependence (except nicotine dependence) within the past 2 years
  • Use of experimental amyloid-lowering therapies use within 2 months before first testing; participation in any other investigational study or received an investigational drug within 30 days or 5 half-lives (whichever is longer) prior to first testing
  • Any surgical or medical condition that may significantly alter the absorption of any drug substance
  • Reside in hospital or moderate- to high-dependency continuous care facility
  • Nonambulatory or wheelchair-bound
  • History of swallowing difficulties

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: T3D Therapeutics, Inc.

Source: ID: NCT02560753

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