Trial Outcomes & Findings for Feasibility Study in Subjects With Mild to Moderate Alzheimer's Disease (NCT NCT02560753)
NCT ID: NCT02560753
Last Updated: 2018-07-30
Results Overview
Changes in relative brain glucose metabolism (delta R CMRgl) were measured by FDG-PET. At each time point, a ratio of the PET reading in a pre-defined region of interest (sROI), known to be affected by AD, and in a reference region (RR) that is spared in AD, is determined. This ratio is defined as "sROI index" (spared region). A second RR, brain white matter (WM), was also used in this calculation: sROI index" (WM) value. delta sROI is defined as change in the sROI index values, over the treatment period. In this study we are looking for changes in delta sROI with increasing doses of T3D-959. Dose dependent changes in delta sROI (AD spared) are compared to those observed with the WM as the RR: delta sROI (WM). Dose related changes in delta sROI suggests T3D-959 is entering the brain and effecting glucose metabolism in a dose dependent fashion.
COMPLETED
PHASE1/PHASE2
36 participants
after 14 days of treatment
2018-07-30
Participant Flow
Participant milestones
| Measure |
T3D-959 3mg
subjects took 3mg by mouth once daily for two weeks, with or without food.
T3D-959: The 3mg dosage was supplied as 1mg capsules (three capsules, taken once daily by mouth)
|
T3D-959 10mg
subjects took 10mg by mouth once daily for two weeks, with or without food.
The 10mg dosage was supplied as 5mg capsules (two capsules, taken once daily by mouth)
|
T3D-959 30mg
subjects took 30mg by mouth once daily for two weeks, with or without food.
The 30mg dosage was supplied as either 5mg or 15mg capsules (six 5mg capsules or two 15mg capsules taken once daily by mouth)
|
T3D-959 90mg
subjects took 90mg by mouth once daily for two weeks, with or without food.
The 90mg dosage was supplied as 15mg capsules (six capsules, taken once daily by mouth)
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
9
|
9
|
10
|
8
|
|
Overall Study
COMPLETED
|
8
|
9
|
9
|
8
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
1
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
This measure is assessed on study completers
Baseline characteristics by cohort
| Measure |
T3D-959 3mg
n=9 Participants
subjects took 3mg by mouth once daily for two weeks, with or without food.
T3D-959: The 3mg dosage was supplied as 1mg capsules (three capsules, taken once daily by mouth)
|
T3D-959 10mg
n=9 Participants
subjects took 10mg by mouth once daily for two weeks, with or without food.
The 10mg dosage was supplied as 5mg capsules (two capsules, taken once daily by mouth)
|
T3D-959 30mg
n=10 Participants
subjects took 30mg by mouth once daily for two weeks, with or without food.
The 30mg dosage was supplied as either 5mg or 15mg capsules (six 5mg capsules or two 15mg capsules taken once daily by mouth)
|
T3D-959 90mg
n=8 Participants
subjects took 90mg by mouth once daily for two weeks, with or without food.
The 90mg dosage was supplied as 15mg capsules (six capsules, taken once daily by mouth)
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Customized
<=65 years
|
2 Participants
n=9 Participants
|
2 Participants
n=9 Participants
|
3 Participants
n=10 Participants
|
1 Participants
n=8 Participants
|
8 Participants
n=36 Participants
|
|
Age, Customized
65-74 years
|
2 Participants
n=9 Participants
|
4 Participants
n=9 Participants
|
2 Participants
n=10 Participants
|
2 Participants
n=8 Participants
|
10 Participants
n=36 Participants
|
|
Age, Customized
75-84 years
|
3 Participants
n=9 Participants
|
3 Participants
n=9 Participants
|
1 Participants
n=10 Participants
|
5 Participants
n=8 Participants
|
12 Participants
n=36 Participants
|
|
Age, Customized
>84 years
|
2 Participants
n=9 Participants
|
0 Participants
n=9 Participants
|
4 Participants
n=10 Participants
|
0 Participants
n=8 Participants
|
6 Participants
n=36 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=9 Participants
|
5 Participants
n=9 Participants
|
6 Participants
n=10 Participants
|
4 Participants
n=8 Participants
|
20 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=9 Participants
|
4 Participants
n=9 Participants
|
4 Participants
n=10 Participants
|
4 Participants
n=8 Participants
|
16 Participants
n=36 Participants
|
|
ApoE4 genotype
ApoE4 positive
|
4 Participants
n=8 Participants • This measure is assessed on study completers
|
2 Participants
n=9 Participants • This measure is assessed on study completers
|
4 Participants
n=9 Participants • This measure is assessed on study completers
|
3 Participants
n=8 Participants • This measure is assessed on study completers
|
13 Participants
n=34 Participants • This measure is assessed on study completers
|
|
ApoE4 genotype
ApoE4 negative
|
4 Participants
n=8 Participants • This measure is assessed on study completers
|
7 Participants
n=9 Participants • This measure is assessed on study completers
|
5 Participants
n=9 Participants • This measure is assessed on study completers
|
5 Participants
n=8 Participants • This measure is assessed on study completers
|
21 Participants
n=34 Participants • This measure is assessed on study completers
|
PRIMARY outcome
Timeframe: after 14 days of treatmentPopulation: Both + \& - values for delta sROI represent "better outcomes" with regard to the demonstrating pharmacological activity of a PPAR delta, such as T3D-959, in the brain. It is unknown at this time, both from this presented data and from the literature, whether the pharmacological action of a PPAR delta agonist will translate to better outcomes in AD.
Changes in relative brain glucose metabolism (delta R CMRgl) were measured by FDG-PET. At each time point, a ratio of the PET reading in a pre-defined region of interest (sROI), known to be affected by AD, and in a reference region (RR) that is spared in AD, is determined. This ratio is defined as "sROI index" (spared region). A second RR, brain white matter (WM), was also used in this calculation: sROI index" (WM) value. delta sROI is defined as change in the sROI index values, over the treatment period. In this study we are looking for changes in delta sROI with increasing doses of T3D-959. Dose dependent changes in delta sROI (AD spared) are compared to those observed with the WM as the RR: delta sROI (WM). Dose related changes in delta sROI suggests T3D-959 is entering the brain and effecting glucose metabolism in a dose dependent fashion.
Outcome measures
| Measure |
T3D-959 3mg
n=9 Participants
subjects took 3mg by mouth once daily for two weeks, with or without food.
T3D-959: The 3mg dosage was supplied as 1mg capsules (three capsules, taken once daily by mouth)
|
T3D-959 10mg
n=9 Participants
subjects took 10mg by mouth once daily for two weeks, with or without food.
The 10mg dosage was supplied as 5mg capsules (two capsules, taken once daily by mouth)
|
T3D-959 30mg
n=10 Participants
subjects took 30mg by mouth once daily for two weeks, with or without food.
The 30mg dosage was supplied as either 5mg or 15mg capsules (six 5mg capsules or two 15mg capsules taken once daily by mouth)
|
T3D-959 90mg
n=8 Participants
subjects took 90mg by mouth once daily for two weeks, with or without food.
The 90mg dosage was supplied as 15mg capsules (six capsules, taken once daily by mouth)
|
|---|---|---|---|---|
|
Change From Baseline (End of Treatment - Baseline) for FDG-PET Imaging With Whole Brain and White Matter as Reference Region
delta sROI (AD spared)
|
0.0015 ratio
Standard Deviation 0.02057
|
0.0034 ratio
Standard Deviation 0.01671
|
-0.0204 ratio
Standard Deviation 0.01952
|
-0.0293 ratio
Standard Deviation 0.01744
|
|
Change From Baseline (End of Treatment - Baseline) for FDG-PET Imaging With Whole Brain and White Matter as Reference Region
delta sROI (white matter)
|
0.0016 ratio
Standard Deviation 0.04008
|
0.0053 ratio
Standard Deviation 0.02471
|
-0.0200 ratio
Standard Deviation 0.01979
|
-0.0355 ratio
Standard Deviation 0.02303
|
PRIMARY outcome
Timeframe: after 14 days of treatmentChanges in BOLD fMRI parameters such as GoF (see Study Description) over the course of two weeks of treatment, were obtained in this study. BOLD fMRI has been used in cross sectional and longitudinal studies of Alzheimer's subjects, for instance in the Alzheimer's Disease Neuroimaging Initiative studies. However, no studies monitoring Default Mode Networks measured parameters such as GoF, in the context of an effective AD therapeutic, as a result it is difficult to interpret the observed small changes listed in BOLD fMRI parameters obtained in this trial. Instead the changes in the listed BOLD fMRI parameters (EOT - BL) are reported without interpretation. These values represent changes in fMRI connectivity patterns over time and are unitless.
Outcome measures
| Measure |
T3D-959 3mg
n=8 Participants
subjects took 3mg by mouth once daily for two weeks, with or without food.
T3D-959: The 3mg dosage was supplied as 1mg capsules (three capsules, taken once daily by mouth)
|
T3D-959 10mg
n=9 Participants
subjects took 10mg by mouth once daily for two weeks, with or without food.
The 10mg dosage was supplied as 5mg capsules (two capsules, taken once daily by mouth)
|
T3D-959 30mg
n=9 Participants
subjects took 30mg by mouth once daily for two weeks, with or without food.
The 30mg dosage was supplied as either 5mg or 15mg capsules (six 5mg capsules or two 15mg capsules taken once daily by mouth)
|
T3D-959 90mg
n=8 Participants
subjects took 90mg by mouth once daily for two weeks, with or without food.
The 90mg dosage was supplied as 15mg capsules (six capsules, taken once daily by mouth)
|
|---|---|---|---|---|
|
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.
GoF (Goodness of Fit)
|
0.0129 unitless
Standard Deviation 0.08528
|
-0.0120 unitless
Standard Deviation 0.0646
|
0.0118 unitless
Standard Deviation 0.03375
|
0.0076 unitless
Standard Deviation 0.08755
|
|
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.
Hippo-PreC Link (Hippocampus - Precuneus Link)
|
-0.1213 unitless
Standard Deviation 0.17904
|
0.1320 unitless
Standard Deviation 0.22964
|
0.1196 unitless
Standard Deviation 0.23035
|
-0.0349 unitless
Standard Deviation 0.18496
|
|
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.
GlobEff_DMN(Global Efficiency from DMN Regions)
|
0.0033 unitless
Standard Deviation 0.00734
|
-0.0036 unitless
Standard Deviation 0.00940
|
-0.0004 unitless
Standard Deviation 0.00926
|
-0.0001 unitless
Standard Deviation 0.00397
|
|
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.
GlobEff_AAL(Global Efficiency from AAL Regions)
|
-0.0001 unitless
Standard Deviation 0.00664
|
-0.0006 unitless
Standard Deviation 0.00972
|
-0.0031 unitless
Standard Deviation 0.01060
|
-0.0005 unitless
Standard Deviation 0.00517
|
|
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.
ALFF_lPCC_PreC (Amplitude of Low Frequency Fluctua
|
-0.0578 unitless
Standard Deviation 0.12314
|
-0.0190 unitless
Standard Deviation 0.11983
|
-0.0505 unitless
Standard Deviation 0.07463
|
-0.0206 unitless
Standard Deviation 0.10508
|
|
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.
ALFF_rPCC_PreC (ALFF from right PCC and precuneus)
|
-0.0752 unitless
Standard Deviation 0.09059
|
-0.0127 unitless
Standard Deviation 0.12127
|
-0.0097 unitless
Standard Deviation 0.08362
|
-0.0325 unitless
Standard Deviation 0.11092
|
|
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.
fALFF_lPCC_PreC (Ratio ALFF from left PCC & prec
|
0.0121 unitless
Standard Deviation 0.03246
|
0.0068 unitless
Standard Deviation 0.03510
|
-0.0132 unitless
Standard Deviation 0.03955
|
-0.0167 unitless
Standard Deviation 0.03284
|
|
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.
fALFF_rPCC_PreC (Ratio ALFF from right PCC & pre
|
-0.0080 unitless
Standard Deviation 0.04094
|
0.0084 unitless
Standard Deviation 0.04325
|
-0.0007 unitless
Standard Deviation 0.03913
|
-0.0118 unitless
Standard Deviation 0.04236
|
|
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.
ReHo_lPCC_PreC (Regional Homogeneity in left PCC a
|
-0.0665 unitless
Standard Deviation 0.18502
|
0.0237 unitless
Standard Deviation 0.14028
|
-0.0369 unitless
Standard Deviation 0.09702
|
0.0194 unitless
Standard Deviation 0.20061
|
|
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.
ReHo_rPCC_PreC (Regional Homogeneity in right PCC
|
-0.0390 unitless
Standard Deviation 0.06406
|
-0.0663 unitless
Standard Deviation 0.22082
|
-0.0895 unitless
Standard Deviation 0.10541
|
-0.0041 unitless
Standard Deviation 0.15836
|
|
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.
ALFF_lIPL (ALFF from left inferior parietal lobule
|
-0.0635 unitless
Standard Deviation 0.09445
|
0.0104 unitless
Standard Deviation 0.05763
|
-0.0102 unitless
Standard Deviation 0.12016
|
-0.0401 unitless
Standard Deviation 0.05657
|
|
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.
ALFF_rIPL(ALFF from right IPL)
|
-0.0493 unitless
Standard Deviation 0.11288
|
-0.0276 unitless
Standard Deviation 0.12720
|
0.0346 unitless
Standard Deviation 0.09654
|
-0.1089 unitless
Standard Deviation 0.13935
|
|
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.
fALFF_lIPL (Ratio ALFF from left IPL)
|
-0.0296 unitless
Standard Deviation 0.03988
|
0.0164 unitless
Standard Deviation 0.02269
|
-0.0107 unitless
Standard Deviation 0.06563
|
-0.0350 unitless
Standard Deviation 0.04570
|
|
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.
fALFF_rIPL (Ratio ALFF from right IPL)
|
-0.0342 unitless
Standard Deviation 0.03912
|
0.0061 unitless
Standard Deviation 0.03286
|
0.0023 unitless
Standard Deviation 0.02771
|
-0.0395 unitless
Standard Deviation 0.05327
|
|
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.
ReHo_lIPL (Regional Homogeneity in left IPL)
|
-0.0694 unitless
Standard Deviation 0.15420
|
0.0147 unitless
Standard Deviation 0.14620
|
-0.0249 unitless
Standard Deviation 0.19178
|
-0.0062 unitless
Standard Deviation 0.06575
|
|
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.
ReHo_rIPL (Regional Homogeneity in right IPL)
|
-0.0694 unitless
Standard Deviation 0.15420
|
0.0147 unitless
Standard Deviation 0.14620
|
-0.0249 unitless
Standard Deviation 0.19178
|
-0.0062 unitless
Standard Deviation 0.06575
|
SECONDARY outcome
Timeframe: after 14 days of treatmentPopulation: 3 mg group:A subject Dc'd prior to the EOT \& another subject became uncooperative at EOT and refused to take the DSST. Her results for EOT were missing. 30 mg: A subject DC'd prior to EOT, another subject was described as being very agitated at the EOT. The results presented omitted this subject's EOT data.
The digit symbol substitution test assesses attention, psychomotor speed, complex scanning, visual tracking, and immediate memory. This test consists of 4 rows each with 25 small blank squares; above each square is a number between 1 and 9. At the top is a 'key,' which pairs each number (1 through 9) with an unfamiliar symbol. The participant has 90 seconds to work as quickly as possible (left to right across the rows) to fill in each blank square with the appropriate symbol based on the number above the square. Results are presented as total number correct; therefore, lower numbers indicate greater impairment. Scores on the DSST range from 0-93.
Outcome measures
| Measure |
T3D-959 3mg
n=9 Participants
subjects took 3mg by mouth once daily for two weeks, with or without food.
T3D-959: The 3mg dosage was supplied as 1mg capsules (three capsules, taken once daily by mouth)
|
T3D-959 10mg
n=9 Participants
subjects took 10mg by mouth once daily for two weeks, with or without food.
The 10mg dosage was supplied as 5mg capsules (two capsules, taken once daily by mouth)
|
T3D-959 30mg
n=10 Participants
subjects took 30mg by mouth once daily for two weeks, with or without food.
The 30mg dosage was supplied as either 5mg or 15mg capsules (six 5mg capsules or two 15mg capsules taken once daily by mouth)
|
T3D-959 90mg
n=8 Participants
subjects took 90mg by mouth once daily for two weeks, with or without food.
The 90mg dosage was supplied as 15mg capsules (six capsules, taken once daily by mouth)
|
|---|---|---|---|---|
|
Change From Baseline in the Score of the Digit Symbol Substitution Test
Change from baseline at end of treatment (day 14)
|
4.429 score on a scale
Standard Deviation 9.1626
|
1.000 score on a scale
Standard Deviation 5.500
|
0.750 score on a scale
Standard Deviation 3.6154
|
1.125 score on a scale
Standard Deviation 4.5493
|
|
Change From Baseline in the Score of the Digit Symbol Substitution Test
Change from baseline at follow-up (day 21)
|
5.375 score on a scale
Standard Deviation 8.5011
|
3.111 score on a scale
Standard Deviation 5.0111
|
4.000 score on a scale
Standard Deviation 5.6789
|
6.625 score on a scale
Standard Deviation 11.4385
|
SECONDARY outcome
Timeframe: after 14 days of treatmentPopulation: 3 mg group:A subject Dc'd prior to the EOT \& another subject became uncooperative at EOT and refused to take the DSST. Her results for EOT were missing. 30 mg: A subject DC'd prior to EOT, another subject was described as being very agitated at the EOT. The results presented omitted this subject's EOT data.
The 11-item Alzheimer's Disease Assessment Scale (ADAS-Cog 11) is a psychometric instrument that evaluates memory, attention, reasoning, language, orientation, and praxis. The score can range between 0 and 70. A higher score indicates more cognitive impairment. A positive change in the score indicates cognitive worsening. The minimum severity score is 0 and the maximum severity score is 70.
Outcome measures
| Measure |
T3D-959 3mg
n=9 Participants
subjects took 3mg by mouth once daily for two weeks, with or without food.
T3D-959: The 3mg dosage was supplied as 1mg capsules (three capsules, taken once daily by mouth)
|
T3D-959 10mg
n=9 Participants
subjects took 10mg by mouth once daily for two weeks, with or without food.
The 10mg dosage was supplied as 5mg capsules (two capsules, taken once daily by mouth)
|
T3D-959 30mg
n=10 Participants
subjects took 30mg by mouth once daily for two weeks, with or without food.
The 30mg dosage was supplied as either 5mg or 15mg capsules (six 5mg capsules or two 15mg capsules taken once daily by mouth)
|
T3D-959 90mg
n=8 Participants
subjects took 90mg by mouth once daily for two weeks, with or without food.
The 90mg dosage was supplied as 15mg capsules (six capsules, taken once daily by mouth)
|
|---|---|---|---|---|
|
Change From Baseline in the Total Score of the 11-item Alzheimer's Disease Assessment Scale - Cognitive Subscale
Change from baseline at end of treatment (day 14)
|
-2.367 score on a scale
Standard Deviation 4.0417
|
-0.552 score on a scale
Standard Deviation 3.1467
|
-2.709 score on a scale
Standard Deviation 3.9801
|
1.970 score on a scale
Standard Deviation 5.2191
|
|
Change From Baseline in the Total Score of the 11-item Alzheimer's Disease Assessment Scale - Cognitive Subscale
Change from baseline at follow-up (day 21)
|
-3.409 score on a scale
Standard Deviation 3.5168
|
-0.624 score on a scale
Standard Deviation 3.8134
|
-4.119 score on a scale
Standard Deviation 3.8163
|
2.795 score on a scale
Standard Deviation 4.1567
|
OTHER_PRE_SPECIFIED outcome
Timeframe: after 14 days of treatmentPopulation: 3 mg group:A subject Dc'd prior to the EOT \& another subject became uncooperative at EOT and refused to take the DSST. Her results for EOT were missing. 30 mg: A subject DC'd prior to EOT, another subject was described as being very agitated at the EOT. The results presented omitted this subject's EOT data.
Number of participants with treatment related adverse events (AEs) as assessed by analysis of adverse events, including symptoms, and abnormal findings on physical and neurological examinations, and standard labs.
Outcome measures
| Measure |
T3D-959 3mg
n=9 Participants
subjects took 3mg by mouth once daily for two weeks, with or without food.
T3D-959: The 3mg dosage was supplied as 1mg capsules (three capsules, taken once daily by mouth)
|
T3D-959 10mg
n=9 Participants
subjects took 10mg by mouth once daily for two weeks, with or without food.
The 10mg dosage was supplied as 5mg capsules (two capsules, taken once daily by mouth)
|
T3D-959 30mg
n=10 Participants
subjects took 30mg by mouth once daily for two weeks, with or without food.
The 30mg dosage was supplied as either 5mg or 15mg capsules (six 5mg capsules or two 15mg capsules taken once daily by mouth)
|
T3D-959 90mg
n=8 Participants
subjects took 90mg by mouth once daily for two weeks, with or without food.
The 90mg dosage was supplied as 15mg capsules (six capsules, taken once daily by mouth)
|
|---|---|---|---|---|
|
Safety and Tolerability of Treatment With T3D-959 Over a 2-week Period in Subjects With Mild-to-moderate AD. New
Subjects with at Least One Serious Adverse Events
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Safety and Tolerability of Treatment With T3D-959 Over a 2-week Period in Subjects With Mild-to-moderate AD. New
Subjects with at Least One Drug-related AE
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Safety and Tolerability of Treatment With T3D-959 Over a 2-week Period in Subjects With Mild-to-moderate AD. New
Subjects with at Least One mild AE
|
2 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Safety and Tolerability of Treatment With T3D-959 Over a 2-week Period in Subjects With Mild-to-moderate AD. New
Subjects with at Least One moderate AE
|
1 participants
|
0 participants
|
2 participants
|
0 participants
|
|
Safety and Tolerability of Treatment With T3D-959 Over a 2-week Period in Subjects With Mild-to-moderate AD. New
Subjects with at Least One serious AE
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
Adverse Events
T3D-959 3mg
T3D-959 10mg
T3D-959 30mg
T3D-959 90mg
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
T3D-959 3mg
n=9 participants at risk
subjects took 3mg by mouth once daily for two weeks, with or without food.
T3D-959: The 3mg dosage was supplied as 1mg capsules (three capsules, taken once daily by mouth)
|
T3D-959 10mg
n=9 participants at risk
subjects took 10mg by mouth once daily for two weeks, with or without food.
The 10mg dosage was supplied as 5mg capsules (two capsules, taken once daily by mouth)
|
T3D-959 30mg
n=10 participants at risk
subjects took 30mg by mouth once daily for two weeks, with or without food.
The 30mg dosage was supplied as either 5mg or 15mg capsules (six 5mg capsules or two 15mg capsules taken once daily by mouth)
|
T3D-959 90mg
n=8 participants at risk
subjects took 90mg by mouth once daily for two weeks, with or without food.
The 90mg dosage was supplied as 15mg capsules (six capsules, taken once daily by mouth)
|
|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Muscular Weakness
|
0.00%
0/9 • pre treatment, during the two weeks of treatment and on follow-up one week after treatment
|
0.00%
0/9 • pre treatment, during the two weeks of treatment and on follow-up one week after treatment
|
10.0%
1/10 • Number of events 1 • pre treatment, during the two weeks of treatment and on follow-up one week after treatment
|
0.00%
0/8 • pre treatment, during the two weeks of treatment and on follow-up one week after treatment
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
11.1%
1/9 • Number of events 1 • pre treatment, during the two weeks of treatment and on follow-up one week after treatment
|
0.00%
0/9 • pre treatment, during the two weeks of treatment and on follow-up one week after treatment
|
0.00%
0/10 • pre treatment, during the two weeks of treatment and on follow-up one week after treatment
|
0.00%
0/8 • pre treatment, during the two weeks of treatment and on follow-up one week after treatment
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place