Alzheimer's DiseasePhase 1/2NCT02560753
Feasibility Study in Subjects With Mild to Moderate Alzheimer's Disease
A Phase 1/2 study testing T3D-959 in people with Alzheimer's Disease, run by T3D Therapeutics, Inc. at 3 sites in United States.
Trial summary
The study is a randomized, parallel, 4-dose design in subjects with mild-to-moderate Alzheimer's Disease. Subjects will be randomized to one of 4 doses of T3D-959. Subjects will be evaluated for changes from baseline in cerebral metabolic rate of glucose (FDG-PET imaging), functional connectivity of the hippocampus… 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?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 3 sitesUnited States
- Study dates
- Jul 2015to 30 Jun 2016
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- 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
Who cannot join
- 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
Show all 26Show fewer
- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
New Hope Clinical Research
Charlotte, North Carolina, 28204
Brain Matters Research
Delray Beach, Florida, 33445
Miami Jewish Health Systems
Miami, Florida, 33137
About this study
Official title: Phase 2a Feasibility Study of T3D-959 in Subjects With Mild to Moderate Alzheimer's Disease
The study is a randomized, parallel, 4-dose design in subjects with mild-to-moderate Alzheimer's Disease. Subjects will be randomized to one of 4 doses of T3D-959. Subjects will be evaluated for changes from baseline in cerebral metabolic rate of glucose (FDG-PET imaging), functional connectivity of the hippocampus (BOLD-fMRI), and cognitive function (ADAS-Cog11 and DSST) as well as assessed for safety and tolerability to T3D-959.
An expanded access extension is planed to provide access to study medication to subjects who have completed the main study and requested continued use.
Read the detailed description
T3D-959 is an orally-delivered, once-a-day administered, small molecule dual nuclear receptor agonist that has been shown in animal and Phase 1 studies in normal human subjects to be safe and well tolerated. The purpose of this clinical study in AD patients is to demonstrate mechanistic proof of concept that T3D-959, can produce desired changes in cerebral glucose metabolism and functional connectivity that may indicate potential for cognitive improvement. The therapeutic approach to be tested is based on two suppositions; (A) ameliorating multiple pathologies in the disease with a single therapy may provide a superior clinical benefit than therapeutic approaches which target a single pathology and (B) correcting insulin resistance in the brain, (highly correlated with AD and potential key driver of AD pathophysiology) and peripherally may be disease remedial.
The brain requires integral insulin signaling for metabolic homeostasis and neuronal plasticity. Insulin resistance disrupts energy balance and signaling networks needed for a broad range of functions. Impaired insulin signaling in neurons enhances apoptosis, promotes oxidative cell death induced by Abeta1-42, increases secretion of Abeta1-42, blocks removal of extracellular Abeta oligomers and increases plaque loads. A growing body of evidence suggests that brain insulin resistance promotes or possibly is the trigger of key pathologies in AD and is supported by observed changes in levels of insulin signaling molecules in AD forebrains and associated changes in memory. Pre-clinical studies in animals have demonstrated the insulin sensitizing activity of T3D-959 and ability to improve multiple pathologies of AD in a rat model of disease.
This non-placebo controlled trial will be conducted in one to three clinical centers. Thirty six (36) patients with mild-to-moderate Alzheimer's disease will be randomly assigned to once daily, orally administered treatment with 3mg, 10mg, 30mg or 90mg doses of T3D-959. Participants will be treated for two weeks and will undergo at baseline and at two weeks; FDG-PET scans to measure brain glucose metabolism, BOLD fMRI scans to measure functional connectivity of the hippocampus, venous blood draws for biomarker analysis and ApoE genotyping, and ADAS-Cog11 and DSST cognitive testing. For monitoring potential toxicities of the drug subjects will undergo physical examination, neurological examination, adverse event review, blood chemistries, and pharmacokinetic (PK) analyses for T3D-959 plasma levels.
BOLD fMRI definition of terms:
GoF (Goodness of Fit): The degree to which the spatial extent and magnitude of one subject's default mode network (DMN) regions matches the one of an elderly control group.
Hippo-PreC Link (Hippocampus - Precuneus Link): The resting-state BOLD signal correlation strength between hippocampus and precuneus regions of interest.
GlobEff_DMN: (Global Efficiency from DMN Regions): The global efficiency among 11 pre-defined default mode network regions.
GlobEff_AAL: (Global Efficiency from AAL Regions): The global efficiency among 90 pre-defined cerebral regions based on automated anatomical labeling.
ALFF_lPCC_PreC: Amplitude of Low Frequency Fluctuations (ALFF) from left posterior cingulate cortex (PCC) and precuneus (PreC).
ALFF_rPCC_PreC: ALFF from right PCC and precuneus. fALFF_lPCC_PreC: Ratio ALFF from left PCC and precuneus. fALFF_rPCC_PreC: Ratio ALFF from right PCC and precuneus. ReHo_lPCC_PreC: Regional Homogeneity in left PCC and PreC. ReHo_rPCC_PreC: Regional Homogeneity in right PCC and PreC. ALFF_lIPL: ALFF from left inferior parietal lobule (IPL). ALFF_rIPL: ALFF from right IPL. fALFF_lIPL: Ratio ALFF from left IPL. fALFF_rIPL : Ratio ALFF from right IPL. ReHo_lIPL: Regional Homogeneity in left IPL. ReHo_rIPL: Regional Homogeneity in right IPL.
Expanded Access Extension: This is an open label 10 visit extension for up to 5 subjects who have completed the T3D959-201 protocol and whose caregivers and physician requested their continued treatment in an expanded access protocol. All subjects enrolled in this study will be treated with a 15mg q.d. dose of T3D959 for six months, regardless of their assigned dose level from the main study. A continued risk/benefit assessment by the investigator will be conducted at each visit to determine the need for treatment continuation. Subjects will be assessed for safety and tolerability to T3D-959 and evaluated for changes from baseline cognitive function via ADAS-Cog11 and DSST testing and global change via CIBIC-plus testing.
- Conditions
- Alzheimer's Disease
- Being tested
- T3D-959
- 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
The 3mg dosage is supplied as 1mg capsules (three capsules, taken once daily by mouth) The 10mg dosage is supplied as 5mg capsules (two capsules, taken once daily by mouth) The 30mg dosage is supplied as either 5mg or 15mg capsules (six 5mg capsules or two 15mg capsules taken once daily by mouth) The 90mg dosage is supplied as 15mg capsules (six capsules, taken once daily by mouth)
| Study group | Role | What they receive |
|---|---|---|
| T3D-959 3mg | Experimental | Nine subjects will take 3mg by mouth once daily for two weeks, with or without food. Receives: Drug: T3D-959 |
| T3D-959 10mg | Experimental | Nine subjects will take 10mg by mouth once daily for two weeks, with or without food. Receives: Drug: T3D-959 |
| T3D-959 30mg | Experimental | Nine subjects will take 30mg by mouth once daily for two weeks, with or without food. Receives: Drug: T3D-959 |
| T3D-959 90mg | Experimental | Nine subjects will take 90mg by mouth once daily for two weeks, with or without food. Receives: Drug: T3D-959 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline (End of Treatment - Baseline) for FDG-PET Imaging With Whole Brain and White Matter as Reference Region
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.
Measured: after 14 days of treatment
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.
Changes 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.
Measured: after 14 days of treatment
Secondary outcomes (2)
Change From Baseline in the Score of the Digit Symbol Substitution Test
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.
Measured: after 14 days of treatment
Change From Baseline in the Total Score of the 11-item Alzheimer's Disease Assessment Scale - Cognitive Subscale
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.
Measured: after 14 days of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2015 (estimated)
- Study startJul 2015
- Primary completion30 May 2016
- Study completion30 Jun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- T3D Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- John Didsbury, Ph.D., Study chair, T3DTherapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02560753
- Sponsor's protocol ID
- T3D959-201
- Status last verified
- Jul 2018
- First submitted
- 28 Jul 2015
- Last updated
- 30 Jul 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Tong M, Dominguez C, Didsbury J, de la Monte SM. Targeting Alzheimer's Disease Neuro-Metabolic Dysfunction with a Small Molecule Nuclear Receptor Agonist (T3D-959) Reverses Disease Pathologies. J Alzheimers Dis Parkinsonism. 2016 Jun;6(3):238. doi: 10.4172/2161-0460.1000238. Epub 2016 Jun 3.
PubMed 27525190Tong M, Deochand C, Didsbury J, de la Monte SM. T3D-959: A Multi-Faceted Disease Remedial Drug Candidate for the Treatment of Alzheimer's Disease. J Alzheimers Dis. 2016;51(1):123-38. doi: 10.3233/JAD-151013.
PubMed 26836193
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2a Feasibility Study of T3D-959 in Subjects With Mild to Moderate Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT02560753
- Acronym / sponsor ID
- T3D959-201
- Conditions
- Alzheimer's Disease
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- T3D Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2015
- Primary completion
- 30 May 2016 (actual)
- Study completion
- 30 Jun 2016 (actual)
- First posted
- 25 Sep 2015 (estimated)
- Results
- Posted 30 Jul 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study is a randomized, parallel, 4-dose design in subjects with mild-to-moderate Alzheimer's Disease. Subjects will be randomized to one of 4 doses of T3D-959. Subjects will be evaluated for changes from baseline in cerebral metabolic rate of glucose (FDG-PET imaging), functional connectivity of the hippocampus (BOLD-fMRI), and cognitive function (ADAS-Cog11 and DSST) as well as assessed for safety and tolerability to T3D-959.
An expanded access extension is planed to provide access to study medication to subjects who have completed the main study and requested continued use.
Detailed description
T3D-959 is an orally-delivered, once-a-day administered, small molecule dual nuclear receptor agonist that has been shown in animal and Phase 1 studies in normal human subjects to be safe and well tolerated. The purpose of this clinical study in AD patients is to demonstrate mechanistic proof of concept that T3D-959, can produce desired changes in cerebral glucose metabolism and functional connectivity that may indicate potential for cognitive improvement. The therapeutic approach to be tested is based on two suppositions; (A) ameliorating multiple pathologies in the disease with a single therapy may provide a superior clinical benefit than therapeutic approaches which target a single pathology and (B) correcting insulin resistance in the brain, (highly correlated with AD and potential key driver of AD pathophysiology) and peripherally may be disease remedial.
The brain requires integral insulin signaling for metabolic homeostasis and neuronal plasticity. Insulin resistance disrupts energy balance and signaling networks needed for a broad range of functions. Impaired insulin signaling in neurons enhances apoptosis, promotes oxidative cell death induced by Abeta1-42, increases secretion of Abeta1-42, blocks removal of extracellular Abeta oligomers and increases plaque loads. A growing body of evidence suggests that brain insulin resistance promotes or possibly is the trigger of key pathologies in AD and is supported by observed changes in levels of insulin signaling molecules in AD forebrains and associated changes in memory. Pre-clinical studies in animals have demonstrated the insulin sensitizing activity of T3D-959 and ability to improve multiple pathologies of AD in a rat model of disease.
This non-placebo controlled trial will be conducted in one to three clinical centers. Thirty six (36) patients with mild-to-moderate Alzheimer's disease will be randomly assigned to once daily, orally administered treatment with 3mg, 10mg, 30mg or 90mg doses of T3D-959. Participants will be treated for two weeks and will undergo at baseline and at two weeks; FDG-PET scans to measure brain glucose metabolism, BOLD fMRI scans to measure functional connectivity of the hippocampus, venous blood draws for biomarker analysis and ApoE genotyping, and ADAS-Cog11 and DSST cognitive testing. For monitoring potential toxicities of the drug subjects will undergo physical examination, neurological examination, adverse event review, blood chemistries, and pharmacokinetic (PK) analyses for T3D-959 plasma levels.
BOLD fMRI definition of terms:
GoF (Goodness of Fit): The degree to which the spatial extent and magnitude of one subject's default mode network (DMN) regions matches the one of an elderly control group.
Hippo-PreC Link (Hippocampus - Precuneus Link): The resting-state BOLD signal correlation strength between hippocampus and precuneus regions of interest.
GlobEff_DMN: (Global Efficiency from DMN Regions): The global efficiency among 11 pre-defined default mode network regions.
GlobEff_AAL: (Global Efficiency from AAL Regions): The global efficiency among 90 pre-defined cerebral regions based on automated anatomical labeling.
ALFF_lPCC_PreC: Amplitude of Low Frequency Fluctuations (ALFF) from left posterior cingulate cortex (PCC) and precuneus (PreC).
ALFF_rPCC_PreC: ALFF from right PCC and precuneus. fALFF_lPCC_PreC: Ratio ALFF from left PCC and precuneus. fALFF_rPCC_PreC: Ratio ALFF from right PCC and precuneus. ReHo_lPCC_PreC: Regional Homogeneity in left PCC and PreC. ReHo_rPCC_PreC: Regional Homogeneity in right PCC and PreC. ALFF_lIPL: ALFF from left inferior parietal lobule (IPL). ALFF_rIPL: ALFF from right IPL. fALFF_lIPL: Ratio ALFF from left IPL. fALFF_rIPL : Ratio ALFF from right IPL. ReHo_lIPL: Regional Homogeneity in left IPL. ReHo_rIPL: Regional Homogeneity in right IPL.
Expanded Access Extension: This is an open label 10 visit extension for up to 5 subjects who have completed the T3D959-201 protocol and whose caregivers and physician requested their continued treatment in an expanded access protocol. All subjects enrolled in this study will be treated with a 15mg q.d. dose of T3D959 for six months, regardless of their assigned dose level from the main study. A continued risk/benefit assessment by the investigator will be conducted at each visit to determine the need for treatment continuation. Subjects will be assessed for safety and tolerability to T3D-959 and evaluated for changes from baseline cognitive function via ADAS-Cog11 and DSST testing and global change via CIBIC-plus testing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| T3D-959 3mg | Experimental | Drug: T3D-959Nine subjects will take 3mg by mouth once daily for two weeks, with or without food. |
| T3D-959 10mg | Experimental | Drug: T3D-959Nine subjects will take 10mg by mouth once daily for two weeks, with or without food. |
| T3D-959 30mg | Experimental | Drug: T3D-959Nine subjects will take 30mg by mouth once daily for two weeks, with or without food. |
| T3D-959 90mg | Experimental | Drug: T3D-959Nine subjects will take 90mg by mouth once daily for two weeks, with or without food. |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (26 listed)
- 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.
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-959The 3mg dosage is supplied as 1mg capsules (three capsules, taken once daily by mouth) The 10mg dosage is supplied as 5mg capsules (two capsules, taken once daily by mouth) The 30mg dosage is supplied as either 5mg or 15mg capsules (six 5mg capsules or two 15mg capsules taken once daily by mouth) The 90mg dosage is supplied as 15mg capsules (six capsules, taken once daily by mouth) | Drug | T3D-959 10mg, T3D-959 30mg, T3D-959 3mg, T3D-959 90mg |
Primary outcome
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
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.
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
Changes 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.
2 secondary outcomes
Change From Baseline in the Score of the Digit Symbol Substitution Test
Time frame: after 14 days of treatment
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 27525190Tong M, Dominguez C, Didsbury J, de la Monte SM. Targeting Alzheimer's Disease Neuro-Metabolic Dysfunction with a Small Molecule Nuclear Receptor Agonist (T3D-959) Reverses Disease Pathologies. J Alzheimers Dis Parkinsonism. 2016 Jun;6(3):238. doi: 10.4172/2161-0460.1000238. Epub 2016 Jun 3.
- Derived from this study: PubMed 26836193Tong M, Deochand C, Didsbury J, de la Monte SM. T3D-959: A Multi-Faceted Disease Remedial Drug Candidate for the Treatment of Alzheimer's Disease. J Alzheimers Dis. 2016;51(1):123-38. doi: 10.3233/JAD-151013.
- 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. This study is not recruiting at the moment.
John Didsbury, Ph.D. study chair
T3DTherapeutics, Inc.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing T3D-959 in people with Alzheimer's Disease, run by T3D Therapeutics, Inc. at 3 sites 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 8 inclusion and 26 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: finished, as of the sponsor's last update on 30 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Jul 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02560753, which also lists 2 linked publications.
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 30 Jul 2018.