T3D-959 for Mild to Moderate Alzheimer's Disease

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?

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.

 

Where Is This Study Located?

Who Sponsors This Study?

Lead: T3D Therapeutics, Inc.

Source: ClinicalTrials.gov ID: NCT02560753