Clinical Study Evaluating Efficacy and Safety of T3D-959 in Mild-to-moderate AD Subjects
Alzheimer Disease
About this trial
This is an interventional treatment trial for Alzheimer Disease focused on measuring mild-to-moderate Alzheimer Disease
Eligibility Criteria
Inclusion Criteria:
- Have a reliable caregiver, an identified adult who, in the opinion of the investigator has sufficient contact to knowledgeably report on the subject's daily cognition, function, behavior, safety, compliance and adherence. Same caregiver(s) must assist the subject throughout the duration of the trial.
- Have a clinical diagnosis of mild-to-moderate AD (Stage 4 or 5) according to the NIA-AA (National Institute of Aging - Alzheimer's Association) criteria at screening
- Meet criteria for mild-to-moderate cognitive impairment with Mini-Mental State Examination (MMSE) score of 14 through 26 at the screening visit.
- Neuroimaging evidence consistent with the diagnosis of AD
- Modified Hachinski </= 4 at screening
- Clinical Dementia Rating is 0.5 to 2.0 at screening and Clinical Dementia Rating - Sum of Boxes is ≥ 3 at screening
- Visual and auditory acuity adequate for neuropsychological testing
- No evidence of hepatic impairment or renal insufficiency
Exclusion Criteria:
- Have a current diagnosis of a significant psychiatric illness per the Diagnostic and Statistical Manual of Mental Disorders V (DSM-V)
- With untreated clinical depression (GDS >/= 6 at screening and baseline)
- Have a current diagnosis of a neurological disease other than AD
- With glycosylated hemoglobin (HbA1c) >/= 7.7 at screening
- With a diagnosis of unstable diabetes
- With clinically significant thyroid disease at screening TSH >5
Have any of the following values at the screening visit:
- ALT and/or AST value that is twice the upper limit of normal
- Total bilirubin value that exceeds 2 mg/dL
- Creatinine level >1.5 mg/dL in men or > 1.4 mg/dL in women
- Positive urinalysis (other than trace result) unless a cause other than renal impairment
- Glomerular filtration rate (GFR) values <54 mL/min/1.73 m2
- Gamma-glutamyl transpeptidase (GGT) value that is twice the upper limit of normal
- Is positive for hepatitis B or anti-hepatitis C virus antibodies at the screening
- Have a history of moderate or severe congestive heart failure, NYHA class III or IV
- Have experienced a previous cardiovascular event (myocardial infarct, by-pass surgery, or PTCA) within the past 12 months prior to the baseline
- Have blood pressure reading at screening that is greater than 160/100 mmHg
- Have a clinically significant unstable illness
- Have a history of HIV infection
- Have a history of alcohol, drug abuse or dependence
- Have a history of cancer within 5 years of the screening
- Have any surgical or medical condition which may significantly alter the absorption of any drug substance
- Females who are pregnant, nursing or of childbearing potential and not practicing effective contraception
- Is required to take excluded medications as specified protocol
- Have a known or suspected intolerance or hypersensitivity to the study drug, closely related compounds
- Resides in hospital or moderate to high dependency continuous care facility
- Are non-ambulatory, or wheelchair-bound
- Have 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
- History of swallowing difficulties
Sites / Locations
- Cognitive Clinical Trials, LLC
- Imaging Endpoints
- National Research Institute
- Pacific Research Network
- CITrials
- Syrentis Clinical Research
- Mile High Research Center
- Research Center for Clinical Studies
- Indago Research and Health Center
- Infinity Clinical Research
- Charter Research - Lady Lake
- ClinCloud, LLC
- Merritt Island Medical Research, LLC
- Health Care Family Rehab and Research Center
- Premier Clinical Research Institute, Inc.
- CCM Clinical Research Group
- Visionary Investigators Network
- Miami Jewish Health
- Elite Clinical Research
- Allied Biomedical Research Institute
- Global Life Research
- Miami Dade Medical Research Institute, LLC
- The Neurology Research Group
- Suncoast Clinical Research
- Headlands Research Orlando
- Advanced Research Consultants
- IMIC Research
- Visionary Investigators Network
- Santos Research Center
- ClinCloud Clinical Research
- iResearch Atlanta
- Center for Advanced Research & Education
- Hawaii Pacific Neuroscience
- Community Hospital of Anderson and Madison County Inc.
- American health Network-Avon
- PharmaSite Research
- Neurology Center of Las Vegas
- Dent Neurologic Institute
- Integrative Clinical Trials, LLC
- Clarity Clinical Research
- Manhattan Behavioral Medicine
- Richmond Behavioral Associates
- New Hope Clinical Research
- ANI Neurology, PLLC dba Alzheimer's Memory Center
- Central States Research, LLC
- Palmetto Clinical Research
- Clinical Trial Network
- Mercury Clinical Research
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Placebo Comparator
Experimental
Experimental
Experimental
Placebo
15mg T3D-959
30mg T3D-959
45mg T3D-959
Placebo, matching T3D-959 active capsules, is pregelatinized starch NF, magnesium stearate NF, and size 0, hard gelatin, white/white, opaque, unmarked capsules. Subjects randomized to placebo will ingest three size 0 placebo capsules once per day in the morning.
T3D-959 15 mg dose: T3D-959 is a small molecule dual nuclear receptor agonist that regulates transcription of genes, in particular those involved in glucose energy and lipid metabolism. T3D-959 is 15-times more potent for PPAR delta than for the secondary target of the drug, PPAR gamma. The 15 mg strength contains 15mg T3D-959, pregelatinized starch NF, magnesium stearate NF, and size 0, hard gelatin, white/white, opaque, unmarked capsules. Subjects will ingest one size 0, 15mg capsule and two placebo capsules once per day in the morning.
T3D-959 30 mg dose: Subjects will ingest two size 0, 15mg capsules and one placebo capsule once per day in the morning.
T3D-959 45 mg dose: Subjects will ingest three size 0, 15mg capsules once per day in the morning.