News Article

T3D-959 for Mild to Moderate Alzheimer's Disease
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Featured firm in this article: T3D Therapeutics Inc of Research Triangle Park, NC

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.
Patient Qualifications:

Min Age Max Age Gender Healthy Volunteers
50 Years 90 Years Both No

Inclusion Criteria:

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

Exclusion Criteria:

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

Detailed Description:

In this Phase II clinical trial, participants will be randomly assigned to take one of four doses of the study drug, T3D-959, a capsule taken once per day for 2 weeks. They will take cognitive tests and undergo brain scans (magnetic resonance imaging and positron emission tomography) and blood tests.

T3D-959 is a small molecule dual nuclear receptor agonist being tested as a potential treatment for Alzheimer's disease. It has been shown to have insulin-sensitizing activity in rats, with the ability to improve multiple pathologies of Alzheimer's disease. It is safe and well tolerated in humans. The drug helps correct insulin resistance in the brain, which is highly correlated with Alzheimer's disease and may be a key driver of Alzheimer's pathology.

Map Marker City State Zip Code Primary Contact

Brain Matters Research

Delray Beach




Miami Jewish Health Systems





New Hope Clinical Research


North Carolina


Lead Sponsor:
T3D Therapeutics, Inc.
Collaborator Sponsor:
Facility Investigators:

Name Role Affiliation
Mark Brody, MD

Principal Investigator

Brain Matters Research
Study Contact:

Name Phone Email
Jennifer Blasi, MS

Locations ID
NCT02560753 (follow link to view full record on in new window)
Official Title:
Phase 2a Feasibility Study of T3D-959 in Subjects With Mild to Moderate Alzheimer's Disease
Study Start Date:
July 2015
Study End Date:
July 2016
Disease Stage: