A Phase 2b/3 Clinical Study Evaluating T3D-959 in Mild-to-Moderate Alzheimer's Disease Subjects

Starting soon · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Alzheimer's Disease

In brief

This study is a Phase 2b/3 clinical trial of a new candidate drug (T3D-959) to treat patients with mild-to-moderate Alzheimer's. The aims of the trial are to affirm potential therapeutic efficacy and safety observed in earlier clinical trials and assess the potential to modify the course of disease. The drug will be compared to placebo and administered orally to patients once a day for 78 weeks.

Key facts

Study ID

NCT06964230

Run by

T3D Therapeutics, Inc.

People needed

376

Starts

2026-10-26

Expected to finish

2031-06-01

Last updated by the study team

2025-05-09

Who can join

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

You may qualify if…

• 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
• Washout and stability of all concurrent medication according to the exclusion criteria listed below
• Able to swallow oral medications

You may not qualify if…

• 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

Where it is running

• T3D Therapeutics, Inc. — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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