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CompletedPhase 1 / PHASE2Results posted

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

Phase 2a Feasibility Study of T3D-959 in Subjects With Mild to Moderate Alzheimer's Disease

Lead sponsor

T3D Therapeutics, Inc.

Asset

T3D-959

Listed sites

Recruiting sites

Enrollment

actual

Study population

Alzheimer’s disease

Key I/E criteria

•mild-to-moderate AD•MMSE 14-26

Primary endpoints

•Change From Baseline for FDG-PET Imaging With Whole Brain•Effect of Treatment With T3D-959 on Changes in Resting State Blood Oxygen Level

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT02560753

Org study IDT3D959-201

Timeline

Milestones

Study start2015-07 (month precision)

Study first posted2015-09-25estimated

Primary completion2016-05-30actual

Study completion2016-06-30actual

Last update posted2018-07-30actual

Results first posted2018-07-30actual

Assets

Drug assets

T3D-959

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age50 Years

Maximum age90 Years

SexAll

Healthy volunteersNot accepted

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

Endpoints (10)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Neuroimaging

Global cognition

Memory

Safety / tolerability / PK

Global cognition

2 endpoints

Secondary/protocol endpoint

Change From Baseline in the Total Score of the 11-item Alzheimer's Disease Assessment Scale - Cognitive Subscale

Time frame:after 14 days of treatment

ADAS-Cog

change from baseline, improvement

Secondary/registry result

Change From Baseline in the Total Score of the 11-item Alzheimer's Disease Assessment Scale - Cognitive Subscale

Time frame:after 14 days of treatment

ADAS-Cog

change from baseline, improvement

Posted result

Group	Value (mean), score on a scale	Standard deviation
T3D-959 3mgChange from baseline at end of treatment (day 14)n=8 Participants	-2.367	4.0417
Change from baseline at follow-up (day 21)n=8 Participants	-3.409	3.5168
T3D-959 10mgChange from baseline at end of treatment (day 14)n=9 Participants	-0.552	3.1467
Change from baseline at follow-up (day 21)n=9 Participants	-0.624	3.8134
T3D-959 30mgChange from baseline at end of treatment (day 14)n=8 Participants	-2.709	3.9801
Change from baseline at follow-up (day 21)n=9 Participants	-4.119	3.8163
T3D-959 90mgChange from baseline at end of treatment (day 14)n=8 Participants	1.970	5.2191
Change from baseline at follow-up (day 21)n=8 Participants	2.795	4.1567

Memory

2 endpoints

Secondary/protocol endpoint

Change From Baseline in the Score of the Digit Symbol Substitution Test

Time frame:after 14 days of treatment

change from baseline, improvement

Secondary/registry result

Change From Baseline in the Score of the Digit Symbol Substitution Test

Time frame:after 14 days of treatment

change from baseline, improvement

Posted result

Group	Value (mean), score on a scale	Standard deviation
T3D-959 3mgChange from baseline at end of treatment (day 14)n=7 Participants	4.429	9.1626
Change from baseline at follow-up (day 21)n=8 Participants	5.375	8.5011
T3D-959 10mgChange from baseline at end of treatment (day 14)n=9 Participants	1.000	5.500
Change from baseline at follow-up (day 21)n=9 Participants	3.111	5.0111
T3D-959 30mgChange from baseline at end of treatment (day 14)n=8 Participants	0.750	3.6154
Change from baseline at follow-up (day 21)n=9 Participants	4.000	5.6789
T3D-959 90mgChange from baseline at end of treatment (day 14)n=8 Participants	1.125	4.5493
Change from baseline at follow-up (day 21)n=8 Participants	6.625	11.4385

Neuroimaging

4 endpoints

Primary/protocol endpoint

Change From Baseline (End of Treatment - Baseline) for FDG-PET Imaging With Whole Brain and White Matter as Reference Region

Time frame:after 14 days of treatment

change from baseline, improvement

Primary/protocol endpoint

The Effect of Treatment With T3D-959 on Changes in Resting State Blood Oxygen Level Dependent (BOLD) Signal in Functional Magnetic Resonance Imaging (fMRI) of the Brain Areas Associated With Cognitive Tasks.

Time frame:after 14 days of treatment

descriptive

Primary/registry result

Change From Baseline (End of Treatment - Baseline) for FDG-PET Imaging With Whole Brain and White Matter as Reference Region

Time frame:after 14 days of treatment

change from baseline, improvement

Posted result

Group	Value (mean), ratio	Standard deviation
T3D-959 3mgdelta sROI (AD spared)n=9 Participants	0.0015	0.02057
delta sROI (white matter)n=9 Participants	0.0016	0.04008
T3D-959 10mgdelta sROI (AD spared)n=9 Participants	0.0034	0.01671
delta sROI (white matter)n=9 Participants	0.0053	0.02471
T3D-959 30mgdelta sROI (AD spared)n=10 Participants	-0.0204	0.01952
delta sROI (white matter)n=10 Participants	-0.0200	0.01979
T3D-959 90mgdelta sROI (AD spared)n=8 Participants	-0.0293	0.01744
delta sROI (white matter)n=8 Participants	-0.0355	0.02303

Primary/registry result

Time frame:after 14 days of treatment

descriptive

Posted result

Group	Value (mean), unitless	Standard deviation
T3D-959 3mgGoF (Goodness of Fit)n=8 Participants	0.0129	0.08528
Hippo-PreC Link (Hippocampus - Precuneus Link)n=8 Participants	-0.1213	0.17904
GlobEff_DMN(Global Efficiency from DMN Regions)n=8 Participants	0.0033	0.00734
GlobEff_AAL(Global Efficiency from AAL Regions)n=8 Participants	-0.0001	0.00664
ALFF_lPCC_PreC (Amplitude of Low Frequency Fluctuan=8 Participants	-0.0578	0.12314
ALFF_rPCC_PreC (ALFF from right PCC and precuneus)n=8 Participants	-0.0752	0.09059
fALFF_lPCC_PreC (Ratio ALFF from left PCC & precn=8 Participants	0.0121	0.03246
fALFF_rPCC_PreC (Ratio ALFF from right PCC & pren=8 Participants	-0.0080	0.04094
ReHo_lPCC_PreC (Regional Homogeneity in left PCC an=8 Participants	-0.0665	0.18502
ReHo_rPCC_PreC (Regional Homogeneity in right PCCn=8 Participants	-0.0390	0.06406
ALFF_lIPL (ALFF from left inferior parietal lobulen=8 Participants	-0.0635	0.09445
ALFF_rIPL(ALFF from right IPL)n=8 Participants	-0.0493	0.11288
fALFF_lIPL (Ratio ALFF from left IPL)n=8 Participants	-0.0296	0.03988
fALFF_rIPL (Ratio ALFF from right IPL)n=8 Participants	-0.0342	0.03912
ReHo_lIPL (Regional Homogeneity in left IPL)n=8 Participants	-0.0694	0.15420
ReHo_rIPL (Regional Homogeneity in right IPL)n=8 Participants	-0.0694	0.15420
T3D-959 10mgGoF (Goodness of Fit)n=9 Participants	-0.0120	0.0646
Hippo-PreC Link (Hippocampus - Precuneus Link)n=9 Participants	0.1320	0.22964
GlobEff_DMN(Global Efficiency from DMN Regions)n=9 Participants	-0.0036	0.00940
GlobEff_AAL(Global Efficiency from AAL Regions)n=9 Participants	-0.0006	0.00972
ALFF_lPCC_PreC (Amplitude of Low Frequency Fluctuan=9 Participants	-0.0190	0.11983
ALFF_rPCC_PreC (ALFF from right PCC and precuneus)n=9 Participants	-0.0127	0.12127
fALFF_lPCC_PreC (Ratio ALFF from left PCC & precn=9 Participants	0.0068	0.03510
fALFF_rPCC_PreC (Ratio ALFF from right PCC & pren=9 Participants	0.0084	0.04325
ReHo_lPCC_PreC (Regional Homogeneity in left PCC an=9 Participants	0.0237	0.14028
ReHo_rPCC_PreC (Regional Homogeneity in right PCCn=9 Participants	-0.0663	0.22082
ALFF_lIPL (ALFF from left inferior parietal lobulen=9 Participants	0.0104	0.05763
ALFF_rIPL(ALFF from right IPL)n=9 Participants	-0.0276	0.12720
fALFF_lIPL (Ratio ALFF from left IPL)n=9 Participants	0.0164	0.02269
fALFF_rIPL (Ratio ALFF from right IPL)n=9 Participants	0.0061	0.03286
ReHo_lIPL (Regional Homogeneity in left IPL)n=9 Participants	0.0147	0.14620
ReHo_rIPL (Regional Homogeneity in right IPL)n=9 Participants	0.0147	0.14620
T3D-959 30mgGoF (Goodness of Fit)n=9 Participants	0.0118	0.03375
Hippo-PreC Link (Hippocampus - Precuneus Link)n=9 Participants	0.1196	0.23035
GlobEff_DMN(Global Efficiency from DMN Regions)n=9 Participants	-0.0004	0.00926
GlobEff_AAL(Global Efficiency from AAL Regions)n=9 Participants	-0.0031	0.01060
ALFF_lPCC_PreC (Amplitude of Low Frequency Fluctuan=9 Participants	-0.0505	0.07463
ALFF_rPCC_PreC (ALFF from right PCC and precuneus)n=9 Participants	-0.0097	0.08362
fALFF_lPCC_PreC (Ratio ALFF from left PCC & precn=9 Participants	-0.0132	0.03955
fALFF_rPCC_PreC (Ratio ALFF from right PCC & pren=9 Participants	-0.0007	0.03913
ReHo_lPCC_PreC (Regional Homogeneity in left PCC an=9 Participants	-0.0369	0.09702
ReHo_rPCC_PreC (Regional Homogeneity in right PCCn=9 Participants	-0.0895	0.10541
ALFF_lIPL (ALFF from left inferior parietal lobulen=9 Participants	-0.0102	0.12016
ALFF_rIPL(ALFF from right IPL)n=9 Participants	0.0346	0.09654
fALFF_lIPL (Ratio ALFF from left IPL)n=9 Participants	-0.0107	0.06563
fALFF_rIPL (Ratio ALFF from right IPL)n=9 Participants	0.0023	0.02771
ReHo_lIPL (Regional Homogeneity in left IPL)n=9 Participants	-0.0249	0.19178
ReHo_rIPL (Regional Homogeneity in right IPL)n=9 Participants	-0.0249	0.19178
T3D-959 90mgGoF (Goodness of Fit)n=8 Participants	0.0076	0.08755
Hippo-PreC Link (Hippocampus - Precuneus Link)n=8 Participants	-0.0349	0.18496
GlobEff_DMN(Global Efficiency from DMN Regions)n=8 Participants	-0.0001	0.00397
GlobEff_AAL(Global Efficiency from AAL Regions)n=8 Participants	-0.0005	0.00517
ALFF_lPCC_PreC (Amplitude of Low Frequency Fluctuan=8 Participants	-0.0206	0.10508
ALFF_rPCC_PreC (ALFF from right PCC and precuneus)n=8 Participants	-0.0325	0.11092
fALFF_lPCC_PreC (Ratio ALFF from left PCC & precn=8 Participants	-0.0167	0.03284
fALFF_rPCC_PreC (Ratio ALFF from right PCC & pren=8 Participants	-0.0118	0.04236
ReHo_lPCC_PreC (Regional Homogeneity in left PCC an=8 Participants	0.0194	0.20061
ReHo_rPCC_PreC (Regional Homogeneity in right PCCn=8 Participants	-0.0041	0.15836
ALFF_lIPL (ALFF from left inferior parietal lobulen=8 Participants	-0.0401	0.05657
ALFF_rIPL(ALFF from right IPL)n=8 Participants	-0.1089	0.13935
fALFF_lIPL (Ratio ALFF from left IPL)n=8 Participants	-0.0350	0.04570
fALFF_rIPL (Ratio ALFF from right IPL)n=8 Participants	-0.0395	0.05327
ReHo_lIPL (Regional Homogeneity in left IPL)n=8 Participants	-0.0062	0.06575
ReHo_rIPL (Regional Homogeneity in right IPL)n=8 Participants	-0.0062	0.06575

Safety / tolerability / PK

2 endpoints

Other/protocol endpoint

Safety and Tolerability of Treatment With T3D-959 Over a 2-week Period in Subjects With Mild-to-moderate AD. New

Time frame:after 14 days of treatment

event count, event

Other_pre_specified/registry result

Safety and Tolerability of Treatment With T3D-959 Over a 2-week Period in Subjects With Mild-to-moderate AD. New

Time frame:after 14 days of treatment

event count, event

Posted result

Group	Value (number), participants	Reported bounds
T3D-959 3mgSubjects with at Least One Serious Adverse Eventsn=9 Participants	0	-
Subjects with at Least One Drug-related AEn=9 Participants	0	-
Subjects with at Least One mild AEn=9 Participants	2	-
Subjects with at Least One moderate AEn=9 Participants	1	-
Subjects with at Least One serious AEn=9 Participants	0	-
T3D-959 10mgSubjects with at Least One Serious Adverse Eventsn=9 Participants	0	-
Subjects with at Least One Drug-related AEn=9 Participants	0	-
Subjects with at Least One mild AEn=9 Participants	0	-
Subjects with at Least One moderate AEn=9 Participants	0	-
Subjects with at Least One serious AEn=9 Participants	0	-
T3D-959 30mgSubjects with at Least One Serious Adverse Eventsn=10 Participants	0	-
Subjects with at Least One Drug-related AEn=10 Participants	1	-
Subjects with at Least One mild AEn=10 Participants	1	-
Subjects with at Least One moderate AEn=10 Participants	2	-
Subjects with at Least One serious AEn=10 Participants	0	-
T3D-959 90mgSubjects with at Least One Serious Adverse Eventsn=8 Participants	0	-
Subjects with at Least One Drug-related AEn=8 Participants	0	-
Subjects with at Least One mild AEn=8 Participants	0	-
Subjects with at Least One moderate AEn=8 Participants	0	-
Subjects with at Least One serious AEn=8 Participants	0	-

Publications (2)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.