Trial Radar IA | ||
|---|---|---|
Lo studio clinico NCT06964230 per Malattia di Alzheimer è non ancora in arruolamento. Consulti la vista a schede del Radar degli Studi Clinici e gli strumenti di scoperta IA per tutti i dettagli. Oppure, ponga pure una domanda qui. | ||
A Phase 2b/3 Clinical Study Evaluating T3D-959 in Mild-to-Moderate Alzheimer's Disease Subjects Fase II, Fase III 376
A Phase 2b/3 Randomized, Double-Blind, Placebo-Controlled Multi-Center Study to Evaluate the Safety and Efficacy of T3D-959 in Subjects With Mild-to-Moderate Alzheimer's Disease
- T3D959-301
Fase III
Mild-to-Moderate Alzheimer's Disease Severity
New Drug Treatment Being Tested
Once-a-day oral drug administration
Phase 2b/3 Study T3D959-301
Brain Metabolism
| Gruppo/Braccio di partecipanti | Intervento/Trattamento |
|---|---|
Comparatore placeboPlacebo, matching T3D-959 active capsules Placebo Comparator: 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 two size 0 placebo capsules once per day in the morning. | Comparatore Placebo Placebo used to compare to T3D-959 drug |
Sperimentale30mg T3D-959 Experimental: 30mg T3D-959 Arm Description: Experimental: T3D-959 30 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, magnes...Mostra di più | T3D-959 Experimental:
T3D-959 30 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 capsules contain 15mg T3D-959, pregelatinized starch NF, magnesium stearate NF, and size 0, hard g...Mostra di più |
| Misure di esito | Descrizione della misura | Arco temporale |
|---|---|---|
Change from baseline to end of treatment in ADAS-Cog13 and ADCS-iADL | Primary Efficacy Endpoint
• Co-primary endpoints of Alzheimer's Disease Assessment Scale cognitive subscale, 13-items (ADAS-Cog13) with a score range of 0-85 (higher scores indicating greater dysfunction) and Alzheimer's Disease Cooperative Study Instrumental Activities of Daily Living (ADCS-iADL) with a score range of 0-56 (lower scores indicating worse performance), in subjects with a clinical diagnosis of mild-to-moderate AD and biological diagnosis of AD pathology. ADAS-cog 13 | 78 weeks |
| Misure di esito | Descrizione della misura | Arco temporale |
|---|---|---|
Change from Baseline to End of Treatment in plasma AB42/40 ratio, in subjects with a clinical diagnosis of mild-to-moderate AD and biological diagnosis of AD pathology | 78 weeks | |
Change from Baseline to End of Treatment in disease stage progression on the Clinical Dementia Rating Scale-Global (CDR-Global), in subjects with a clinical diagnosis of mild-to-moderate AD and biological diagnosis of AD pathology | CDR global score has a range of 0-3 with a higher score indicating greater dementia severity | 78 weeks |
Change from baseline to end of treatment in Clinical Dementia Rating Scale - Sum of Boxes (CDR-SB), in subjects with a clinical diagnosis of mild-to-moderate AD and biological diagnosis of AD pathology | CDR-SB has a score range of 0-18 with a higher number indicating greater dementia severity | 78 weeks |
Change from Baseline to End of Treatment on the integrated Alzheimer's Disease Rating Scale (iADRS), in subjects with a clinical diagnosis of mild-to-moderate AD and biological diagnosis of AD pathology | The iADRS is a composite scale that is calculated as a linear combination of total scores of the two individual components, the ADAS-Cog13 (score range 0-85) and the instrumental items of the ADCS-ADL (ADCS-iADL; score range 0-56)1 • The iADRS score ranges from 0-141 with lower scores indicating worse performance. | 78 weeks |
- Male or female subject aged 50-90 years old inclusive at the time of Informed Consent
- Subject (or legal representative) and caregiver must sign an Informed Consent to participate in the study.
- Subject has a caregiver, an identified adult who, in the opinion of the investigator, has sufficient contact to knowledgeably report on the subject's cognition, function, behavior, safety, compliance and adherence. Same caregiver should, whenever possible, assist the subject throughout the duration of the trial
- Subject has a biological diagnosis of AD pathology, as assessed by a validated plasma biomarker (presently %p-tau217 plasma biomarker), according to the NIA-AA (National Institute of Aging - Alzheimer's Association) criteria at screening
- Subject has 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
- Meets criteria for mild-to-moderate cognitive impairment with Mini-Mental State Examination (MMSE) score of 14 through 26 at the screening visit.
- Modified Hachinski < 4 at screening
- Clinical Dementia Rating is 0.5 to 2.0 at screening
- Visual and auditory acuity adequate for neuropsychological testing
- Medical stability for this study as confirmed by review of records, comprehensive physical exam, neurological exam, and laboratory tests
- Able to swallow oral medications
Exclusion Criteria:
Subject has a current diagnosis of a significant psychiatric illness per the Diagnostic and Statistical Manual of Mental Disorders V (DSM-V) including but not limited to major depressive disorder, anxiety disorders and is in an acute phase/episode; or the subject has a current diagnosis or history of schizophrenia or bipolar disorder; or has current signs of suicidality or history of suicide attempt
Subject with untreated clinical depression at screening; Geriatric Depression Scale (GDS) Short Form > 9
Evidence of clinically significant lesion(s) on brain MRI at Screening that could indicate a dementia diagnosis other than Alzheimer's disease
Other significant pathological findings on brain MRI at screening, including but not limited to: more than 4 microhemorrhages (defined as 10 millimeter \[mm\] or less at the greatest diameter); a single macrohemorrhage >10 mm at greatest diameter; an area of superficial siderosis; evidence of vasogenic edema; evidence of cerebral contusion, encephalomalacia, aneurysms, vascular malformations, or infective lesions; evidence of multiple lacunar infarcts or stroke involving a major vascular territory, severe small vessel, or white matter disease; space occupying lesions; or brain tumors (however, lesions diagnosed as meningiomas or arachnoid cysts and <1 centimeter \[cm\] at their greatest diameter need not be exclusionary)
Subject has a current diagnosis of a neurological disease other than AD, which has or could result in cognitive impairment, including, but not limited to, any of the following:
- History of clinically significant stroke or multiple strokes as ascertained by history and/or brain imaging findings, or history of TIA's within 12 months prior to baseline
- History of serious brain infection
- History of or current space occupying cerebral lesion
- History of clinically significant concussion or repeated head trauma associated with sustained cognitive impairment in the last 5 years
- Huntington's Disease
- Parkinson's Disease
- Dementia predominantly of a non-Alzheimer's type (vascular dementia, frontotemporal dementia, Parkinson's dementia, substance-induced dementia)
- Normal pressure hydrocephalus
- History of seizures (except for childhood febrile) or epilepsy
With glycosylated hemoglobin (HbA1c) ≥ 10 at screening
Subject with a diagnosis of unstable diabetes
Subject with clinically significant thyroid disease at screening TSH >5 and abnormal T3/T4
Subject has any evidence of hepatic impairment or renal insufficiency, including any of the following values at the screening visit:
- Serum alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) value that is twice the upper limit of normal
- A serum total bilirubin value that exceeds 2 mg/dL
- Serum creatinine level >1.5 mg/dL in men or > 1.4 mg/dL in women
- Positive urinalysis consistent with renal impairment
- Estimated glomerular filtration rate (eGFR) < 50 mL/min/1.73m2
- Gamma glutamyl-transpeptidase (GGT) twice the upper limit of normal
Subject is positive for hepatitis B surface antigen (HBsAg) or anti-hepatitis C virus (HCV) antibodies at the screening visit
Subject has a history of moderate or severe congestive heart failure, NYHA class III or IV, within 12 months prior to baseline
Subject has experienced a previous cardiovascular event (myocardial infarct, by-pass surgery, or PTCA) within the past 6 months prior to the baseline (visit 2)
Subject has blood pressure reading at screening that is greater than 160/100 mmHg. Subjects with elevated BP will be allowed at the discretion of the principal investigator. Blood pressure will be measured after the subject has been supine for at least 5 minutes followed by repeat measurement after standing for at least 3 minutes. Subjects will be excluded if a significant diastolic (15 mmHg) drop in blood pressure or symptomatic presyncope occurred
Subject has a clinically significant unstable illness, for example hepatic impairment or renal insufficiency, or cardiovascular, pulmonary, gastrointestinal, endocrine, rheumatological, immunological, infection, skin and subcutaneous tissue disorder or metabolic disturbance
Subject has a history of HIV infection
Subject has a history of marijuana abuse or dependence (except topical CBD) within 1 year of the screening visit
Subject has a history of alcohol, drug abuse or dependence (except nicotine dependence) within 2 years of the screening visit
Subject has a history of cancer within 5 years of the screening visit (other than non-melanoma skin cancer, stable non-progressive prostate cancer not requiring treatment or in situ cervical cancer)
Subject has any surgical or medical condition which may significantly alter the absorption of any drug substance including, but not limited to, any of the following:
- History of major gastrointestinal tract surgery (e.g. bariatric surgery)
- Currently active inflammatory bowel syndrome
Female subject who is pregnant, nursing or of childbearing potential and not practicing effective contraception
Subject is required to take excluded medications as specified in the Excluded Medications section below.
Subject has a known or suspected intolerance or hypersensitivity to the study drug, closely related compounds, or any of their stated ingredients
Subject resides in hospital or moderate to high dependency continuous care facility
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
T3D Therapeutics, Inc.North Carolina