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

• Status: Completed
• Trial end date: 2016-06-30
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: T3D Therapeutics, Inc.

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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 :

Subjects must continue to meet the main study inclusion/exclusion criteria to insure continued safety to continue on a 6 months study extension