Feasibility Study in Subjects With Mild to Moderate Alzheimer's Disease

Completed · Phase 1/Phase 2

Conditions studied: Alzheimer's Disease

In brief

The study is a randomized, parallel, 4-dose design in subjects with mild-to-moderate Alzheimer's Disease. Subjects will be randomized to one of 4 doses of T3D-959. Subjects will be evaluated for changes from baseline in cerebral metabolic rate of glucose (FDG-PET imaging), functional connectivity of the hippocampus (BOLD-fMRI), and cognitive function (ADAS-Cog11 and DSST) as well as assessed for safety and tolerability to T3D-959. An expanded access extension is planed to provide access to study medication to subjects who have completed the main study and requested continued use.

Key facts

Study ID: NCT02560753
Run by: T3D Therapeutics, Inc.
People needed: 36
Starts: 2015-07-01
Expected to finish: 2016-06-30
Last updated by the study team: 2018-07-30

Who can join

Age: 50 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Meets criteria for mild-to-moderate AD with Mini-Mental State Examination (MMSE) score of 14 through 26
Clinical Dementia Rating = 0.5 to 2.0
Modified Hachinski less than or equal to 4
A clinical diagnosis of AD per NINCDS-ADRDA criteria
Washout of psychoactive medication (other than anti-depressants): at least 4 weeks prior to baseline
Stability of all permitted medications for 4-12 weeks prior to baseline
Visual and auditory acuity adequate for neuropsychological testing
Home monitoring available for supervision of medications

You may not qualify if…

Unstable diabetes or insulin use
Unable to participate in FDG-PET scanning
Inability to undergo a clinical MRI of the brain
Diagnosis of significant neurological/psychiatric disease other than AD
History of moderate or severe congestive heart failure, NYHA class III or IV, within 12 months prior to baseline.
Previous cardiovascular event within the past 6 months prior to baseline
Subject is 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 history of severe or unstable disorder (medical or psychiatric) requiring treatment that may make the subject unlikely to complete the study.
Current use of fluvoxamine.
Current unstable use of warfarin.
Current use (within 30 days of baseline, visit 2) of certain highly protein-bound medications
Malignancy within the last 5 years (other than non-melanoma skin cancer, stable, non-progressive 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 drugs, closely related compounds, or any of their stated ingredients.
History of alcohol, drug abuse or dependence (except nicotine dependence) within 2 years.
Investigational amyloid lowering therapies use within two months prior to baseline
Have participated in any other investigational study or received an investigational drug within 30 days or 5 half-lives (whichever is longer) prior to baseline
Any surgical or medical condition which may significantly alter the absorption of any drug substance
Resides in hospital or moderate to high dependency continuous care facility.
Non ambulatory, or wheelchair-bound
History of swallowing difficulties.
Evidence of clinically relevant pathology that in the investigator's opinion could interfere with the study results or put the subject's safety at risk.
Expanded Access Extension :

Where it is running

Brain Matters Research — Delray Beach, Florida, United States
Miami Jewish Health Systems — Miami, Florida, United States
New Hope Clinical Research — Charlotte, North Carolina, United States

Full record on ClinicalTrials.gov

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