Alzheimer's DiseasePhase 2/3NCT06964230
A Phase 2b/3 Clinical Study Evaluating T3D-959 in Mild-to-Moderate Alzheimer's Disease Subjects
A Phase 2/3 study testing T3D-959 in people with Alzheimer's Disease, run by T3D Therapeutics, Inc. at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 50 to 90 years
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- T3D-959
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 376 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Oct 2026to Jun 2031
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
T3D Therapeutics, Inc.
Durham, North Carolina, 27713
About this study
Official title: 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
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.
Read the detailed description
This study is a randomized, double-blind, placebo-controlled study of T3D-959 30mg in subjects with clinical mild-to-moderate Alzheimer's Disease and a biological diagnosis of AD pathology, as defined by a validated plasma biomarker (presently %p-tau217 plasma biomarker). This study is designed as a seamless group sequential design where estimates of treatment effect on cognitive and functional scales will be evaluated in an interim analysis by independent statisticians. The sample size will be re-estimated to ensure the study is sufficiently powered to demonstrate efficacy of T3D-959 in cognition and function.
Subjects will be assigned to one of two treatment arms (1:1 ratio) in a randomized, double-blind fashion, stratified by sex and ApoE4 genotype. Study medication will be taken once daily for 78 weeks. Safety/tolerability, efficacy and exploratory assessments will be evaluated for changes from baseline to end of treatment (78 weeks). Subjects will be followed for four weeks after the end of treatment.
- Conditions
- Alzheimer's Disease
- Being tested
- T3D-959, Placebo Comparator
- Keywords
- T3D-959, 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
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
T3D-959Drug
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 gelatin, white/white, opaque, unmarked capsules. Subjects will ingest two size 0, 15mg capsules once per day in the morning.
Placebo ComparatorOther
Placebo used to compare to T3D-959 drug
| Study group | Role | What they receive |
|---|---|---|
| Placebo, matching T3D-959 active capsules | Placebo comparator | 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. Receives: Other: Placebo Comparator |
| 30mg T3D-959 | Experimental | 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, magnesium stearate NF, and size 0, hard gelatin, white/white, opaque, unmarked capsules. Subjects will ingest two size 0, 15mg capsules once per day in the morning. Receives: Drug: T3D-959 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 78 weeks
Secondary outcomes (4)
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
Measured: 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
Measured: 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
Measured: 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.
Measured: 78 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2025
- Study start26 Oct 2026 (estimated)
- Primary completionApr 2031 (estimated)
- Study completionJun 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 376 participants (estimated)
Sponsor and investigators
- Lead sponsor
- T3D Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, John Didsbury, T3D Therapeutics, Inc.
- Investigators
- John Didsbury, Chief Executive Officer, Ph.D, Study director, T3D Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06964230
- Sponsor's protocol ID
- T3D959-301
- Status last verified
- Apr 2025
- First submitted
- 14 Apr 2025
- Last updated
- 9 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06964230
- Acronym / sponsor ID
- T3D959-301
- Conditions
- Alzheimer's Disease
- Keywords
- T3D-959, 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
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 376 participants (estimated)
- Lead sponsor
- T3D Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 26 Oct 2026 (estimated)
- Primary completion
- Apr 2031 (estimated)
- Study completion
- Jun 2031 (estimated)
- First posted
- 9 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study is a randomized, double-blind, placebo-controlled study of T3D-959 30mg in subjects with clinical mild-to-moderate Alzheimer's Disease and a biological diagnosis of AD pathology, as defined by a validated plasma biomarker (presently %p-tau217 plasma biomarker). This study is designed as a seamless group sequential design where estimates of treatment effect on cognitive and functional scales will be evaluated in an interim analysis by independent statisticians. The sample size will be re-estimated to ensure the study is sufficiently powered to demonstrate efficacy of T3D-959 in cognition and function.
Subjects will be assigned to one of two treatment arms (1:1 ratio) in a randomized, double-blind fashion, stratified by sex and ApoE4 genotype. Study medication will be taken once daily for 78 weeks. Safety/tolerability, efficacy and exploratory assessments will be evaluated for changes from baseline to end of treatment (78 weeks). Subjects will be followed for four weeks after the end of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo, matching T3D-959 active capsules | Placebo comparator | Other: Placebo ComparatorPlacebo 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. |
| 30mg T3D-959 | Experimental | Drug: T3D-959Experimental: 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, magnesium stearate NF, and size 0, hard gelatin, white/white, opaque, unmarked capsules. Subjects will ingest two size 0, 15mg capsules once per day in the morning. |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (41 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| T3D-959Experimental: 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 gelatin, white/white, opaque, unmarked capsules. Subjects will ingest two size 0, 15mg capsules once per day in the morning. | Drug | 30mg T3D-959 |
| Placebo ComparatorPlacebo used to compare to T3D-959 drug | Other | Placebo, matching T3D-959 active capsules |
Primary outcome
Change from baseline to end of treatment in ADAS-Cog13 and ADCS-iADL
Time frame: 78 weeks
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
4 secondary outcomes
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 78 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
John Didsbury, Chief Executive Officer, Ph.D study director
T3D Therapeutics, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing T3D-959 in people with Alzheimer's Disease, run by T3D Therapeutics, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 41 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Blake E Swearingen, MS (919-622-3409, blakeswearingen@t3dtherapeutics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline to end of treatment in ADAS-Cog13 and ADCS-iADL (time frame: 78 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2025.