Start: July 2015
End: June 30, 2016
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?
- 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.
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?
Lead: T3D Therapeutics, Inc.
Source: ClinicalTrials.gov ID: NCT02560753