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| Name | Class |
|---|---|
| Alzheimer's Disease Cooperative Study (ADCS) | OTHER |
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The primary objective is to evaluate the efficacy of T-817MA as measured by ADAS-cog and ADCS-CGIC.
The secondary objectives are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| T-817MA-H | Experimental | 224 mg T-817MA once daily for first 4 weeks and 448 mg T-817MA once daily for the following weeks. |
|
| T-817MA-L | Experimental | 224 mg T-817MA once daily |
|
| Placebo | Placebo Comparator | Placebo once daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| T-817MA-H | Drug | 224 mg or 448 mg T-817 MA once daily |
| |
| T-817MA-L |
| Measure | Description | Time Frame |
|---|---|---|
| ADAS-cog Change From Baseline to Week 52 | The ADAS-cog (Alzheimer's Disease Assessment Scale-cognitive subscale) is a structured scale that evaluates memory (word recall, word recognition), reasoning (following commands), language (naming, comprehension), orientation, ideational praxis (placing letter in envelope) and constructional praxis (copying geometric designs). Ratings of spoken language, language comprehension, word finding difficulty, and ability to remember test instructions are also obtained. The test is scored in terms of errors, with higher scores reflecting poorer performance and greater impairment. Scores can range from 0 (best) to 70 (worse). | Baseline and 52 weeks |
| CGIC | The ADCS-CGIC (Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change) is a validated categorical measure of change in the patient's clinical condition between baseline and follow-up visits. It measures whether the effects of active treatment are substantial enough to be detected by a skilled and experienced clinician on the basis of a clinical interview and examination. It relies on both direct examination of the patient and an interview of the study partner. A skilled and experienced clinician who is blinded to treatment assignment rates the patient on a 7-point Likert scale, ranging from 1 (marked improvement) to 7 (marked worsening). It is suggested that the instrument has distinct clinical utility in assessing change in AD clinical trials. | 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| ADCS-ADL Change From Baseline to Week 52 | The ADCS-ADL (Alzheimer's Disease Cooperative Study Activities of Daily Living) is a validated tool for assessing instrumental and basic activities of daily living based on a 23-item structured interview of the study partner. The scale has a range of 0 to 78, with lower scores indicating greater impairment. | Baseline and 52 weeks |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Banner Alzheimer's Institute | Phoenix | Arizona | United States | |||
| Banner Sun Health Research Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31282954 | Derived | Schneider LS, Thomas RG, Hendrix S, Rissman RA, Brewer JB, Salmon DP, Oltersdorf T, Okuda T, Feldman HH; Alzheimer's Disease Cooperative Study TCAD Study Group. Safety and Efficacy of Edonerpic Maleate for Patients With Mild to Moderate Alzheimer Disease: A Phase 2 Randomized Clinical Trial. JAMA Neurol. 2019 Nov 1;76(11):1330-1339. doi: 10.1001/jamaneurol.2019.1868. |
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| ID | Title | Description |
|---|---|---|
| FG000 | T-817MA-H | 224 mg T-817MA once daily for first 4 weeks and 448 mg T-817MA once daily for the following weeks. T-817MA-H: 224 mg or 448 mg T-817 MA once daily |
| FG001 | T-817MA-L |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 12, 2018 |
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| Drug |
224 mg T-817 MA once daily |
|
| Placebo | Drug | Placebo |
|
| Sun City |
| Arizona |
| United States |
| University of Arizona Health Sciences Center | Tucson | Arizona | United States |
| Neurology Center of North Orange County | Fullerton | California | United States |
| UCSD Comprehensive Alzheimer's Program | La Jolla | California | United States |
| UC Irvine Medical Center | Orange | California | United States |
| Geriatric and Adult Psychiatry, LCC | Hamden | Connecticut | United States |
| Yale University, Alzheimer's Disease Research Unit | New Haven | Connecticut | United States |
| Research Center for Clinical Studies, Inc. | Norwalk | Connecticut | United States |
| Georgetown University Clinical Research Unit | Washington D.C. | District of Columbia | United States |
| Infinity Clinical Research, LLC | Hollywood | Florida | United States |
| University of Miami Miller-School of Medicine | Miami | Florida | United States |
| Scientific Clinical Research, Inc | North Miami | Florida | United States |
| Renstar Medical Research | Ocala | Florida | United States |
| Meridien Research | Tampa | Florida | United States |
| Neuro Trials Research, Inc | Atlanta | Georgia | United States |
| Rush University Medical Center | Chicago | Illinois | United States |
| SIU School of Medicine | Springfield | Illinois | United States |
| Indiana Medical Research | Elkhart | Indiana | United States |
| Indiana University Health Partners, Adult Neurology Clinic | Indianapolis | Indiana | United States |
| University of Iowa Hospitals and Clinics | Iowa City | Iowa | United States |
| University of Kansas/Clinical and Translational Science Unit | Fairway | Kansas | United States |
| University of Kentucky Sanders-Brown Center on Aging Clinic | Lexington | Kentucky | United States |
| Pennington Biomedical Research Center | Baton Rouge | Louisiana | United States |
| Acadia Hospital | Bangor | Maine | United States |
| Boston University Alzheimer's Disease Center | Boston | Massachusetts | United States |
| University of Michigan Health System/ Michigan Clinical Research Unit | Ann Arbor | Michigan | United States |
| Michigan State University | East Lansing | Michigan | United States |
| Bronson Neurobehvioral Health | Paw Paw | Michigan | United States |
| University of Nebraska Medical Center(Geri Psych) | Omaha | Nebraska | United States |
| Cleveland Clinic Lou Ruvo Center for Brain Health | Las Vegas | Nevada | United States |
| Global Medical Institutes, LLC;Princeton Medical Institute | Princeton | New Jersey | United States |
| Dent Neurologic Institute | Amherst | New York | United States |
| Alzheimer's Disease Research Center of Mount Sinai | New York | New York | United States |
| Columbia University Medical Center Sergievsky Center Taub Institute | New York | New York | United States |
| The Nathan S. Kline Instituite for Psychiatric Research | Orangeburg | New York | United States |
| University of Rochester Medical Center | Rochester | New York | United States |
| SUNY Upstate Medical University | Syracuse | New York | United States |
| Wake Forest University (WFU) School of Medicine | Winston-Salem | North Carolina | United States |
| Case Western Reserve University/ University Hospitals Case Medical Center | Beachwood | Ohio | United States |
| Tulsa Clinical Research, LLC | Tulsa | Oklahoma | United States |
| Hospital at the University of Pennsylvania, Penn Memory Center | Philadelphia | Pennsylvania | United States |
| University of Pittsburgh, Alzheimer Disease Research Center | Pittsburgh | Pennsylvania | United States |
| Abington Neurological Associates, LTD. | Willow Grove | Pennsylvania | United States |
| Roper St. Francis Healthcare | Charleston | South Carolina | United States |
| Vanderbilt University Medical Center -VUIIS | Nashville | Tennessee | United States |
| University of North Texas Health Science Center | Fort Worth | Texas | United States |
| Houston Methodist Hospital | Houston | Texas | United States |
| University of Wisconsin Hospital and Clinics | Madison | Wisconsin | United States |
| Cary J. Kohlenberg MD., SC dba IPC Research | Waukesha | Wisconsin | United States |
224 mg T-817MA once daily
T-817MA-L: 224 mg T-817 MA once daily
| FG002 | Placebo | Placebo once daily Placebo: Placebo |
| COMPLETED |
|
| NOT COMPLETED |
|
|
The overall numbers of baseline participants display patient numbers in the mITT population, the primary analysis population. The mITT population excludes patients who did not take any study drug or did not perform any efficacy evaluation post-baseline. Thus, the numbers are slightly difference from the ones in the participant flow.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | T-817MA-H | 224 mg T-817MA once daily for first 4 weeks and 448 mg T-817MA once daily for the following weeks. T-817MA-H: 224 mg or 448 mg T-817 MA once daily |
| BG001 | T-817MA-L | 224 mg T-817MA once daily T-817MA-L: 224 mg T-817 MA once daily |
| BG002 | Placebo | Placebo once daily Placebo: Placebo |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| ApoE4 genotype | Count of Participants | Participants |
| ||||||||||||||||
| MMSE | The Mini Mental Scale Examination (MMSE) is a validated, brief, frequently used screening instrument for Alzheimer's disease drug studies. The MMSE scale evaluates orientation, memory, attention, concentration, naming, repetition, comprehension, and ability to create a sentence and to copy two overlapping pentagons. The MMSE is scored as the number of correctly completed items with a lower score indicative of poorer performance and greater cognitive impairment. The total score ranges from 0 (worse) to 30 (perfect performance). | Mean | Standard Deviation | units on a scale |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | ADAS-cog Change From Baseline to Week 52 | The ADAS-cog (Alzheimer's Disease Assessment Scale-cognitive subscale) is a structured scale that evaluates memory (word recall, word recognition), reasoning (following commands), language (naming, comprehension), orientation, ideational praxis (placing letter in envelope) and constructional praxis (copying geometric designs). Ratings of spoken language, language comprehension, word finding difficulty, and ability to remember test instructions are also obtained. The test is scored in terms of errors, with higher scores reflecting poorer performance and greater impairment. Scores can range from 0 (best) to 70 (worse). | The overall number of participants display the numbers of patients who were included in the mITT population and had baseline and at least one post-baseline ADAS-cog evaluation. | Posted | Mean | Standard Error | units on a scale | Baseline and 52 weeks |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | CGIC | The ADCS-CGIC (Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change) is a validated categorical measure of change in the patient's clinical condition between baseline and follow-up visits. It measures whether the effects of active treatment are substantial enough to be detected by a skilled and experienced clinician on the basis of a clinical interview and examination. It relies on both direct examination of the patient and an interview of the study partner. A skilled and experienced clinician who is blinded to treatment assignment rates the patient on a 7-point Likert scale, ranging from 1 (marked improvement) to 7 (marked worsening). It is suggested that the instrument has distinct clinical utility in assessing change in AD clinical trials. | The overall number of participants display the numbers of patients who were included in the mITT population and had at least one post-baseline CGIC evaluation. | Posted | Mean | Standard Error | units on a scale | 52 weeks |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | ADCS-ADL Change From Baseline to Week 52 | The ADCS-ADL (Alzheimer's Disease Cooperative Study Activities of Daily Living) is a validated tool for assessing instrumental and basic activities of daily living based on a 23-item structured interview of the study partner. The scale has a range of 0 to 78, with lower scores indicating greater impairment. | The overall number of participants display the numbers of patients who were included in the mITT population and had baseline and at least one post-baseline ADCS-ADL evaluation. | Posted | Mean | Standard Error | units on a scale | Baseline and 52 weeks |
|
|
52weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | T-817MA-H | 224 mg T-817MA once daily for first 4 weeks and 448 mg T-817MA once daily for the following weeks. T-817MA-H: 224 mg or 448 mg T-817 MA once daily | 2 | 158 | 26 | 158 | 132 | 158 |
| EG001 | T-817MA-L | 224 mg T-817MA once daily T-817MA-L: 224 mg T-817 MA once daily | 2 | 166 | 25 | 166 | 133 | 166 |
| EG002 | Placebo | Placebo once daily Placebo: Placebo | 0 | 158 | 20 | 158 | 119 | 158 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia Macrocytic | Blood and lymphatic system disorders | Non-systematic Assessment |
| ||
| Acute Myocardial Infarction | Cardiac disorders | Non-systematic Assessment |
| ||
| Atrial Fibrillation | Cardiac disorders | Non-systematic Assessment |
| ||
| Atrioventricular Block Complete | Cardiac disorders | Non-systematic Assessment |
| ||
| Bradycardia | Cardiac disorders | Non-systematic Assessment |
| ||
| Cardiac Arrest | Cardiac disorders | Non-systematic Assessment |
| ||
| Myocardial Infarction | Cardiac disorders | Non-systematic Assessment |
| ||
| Vertigo Positional | Ear and labyrinth disorders | Non-systematic Assessment |
| ||
| Diarrhoea | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Duodenal Ulcer Haemorrhage | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Megacolon | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Pancreatitis | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Pancreatitis Acute | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Asthenia | General disorders | Non-systematic Assessment |
| ||
| Chest Pain | General disorders | Non-systematic Assessment |
| ||
| Non-Cardiac Chest Pain | General disorders | Non-systematic Assessment |
| ||
| Cholelithiasis | Hepatobiliary disorders | Non-systematic Assessment |
| ||
| Hepatitis | Hepatobiliary disorders | Non-systematic Assessment |
| ||
| Cellulitis | Infections and infestations | Non-systematic Assessment |
| ||
| Clostridium Difficile Infection | Infections and infestations | Non-systematic Assessment |
| ||
| Cystitis | Infections and infestations | Non-systematic Assessment |
| ||
| Diverticulitis | Infections and infestations | Non-systematic Assessment |
| ||
| Gastroenteritis | Infections and infestations | Non-systematic Assessment |
| ||
| Pneumonia | Infections and infestations | Non-systematic Assessment |
| ||
| Pneumonia Influenzal | Infections and infestations | Non-systematic Assessment |
| ||
| Sepsis | Infections and infestations | Non-systematic Assessment |
| ||
| Urinary Tract Infection | Infections and infestations | Non-systematic Assessment |
| ||
| Fall | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Femoral Neck Fracture | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Femur Fracture | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Hip Fracture | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Humerus Fracture | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Joint Injury | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Laceration | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Multiple Fractures | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Post Procedural Haemorrhage | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Rib Fracture | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Subdural Haematoma | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Dehydration | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Hypokalaemia | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Chondrocalcinosis Pyrophosphate | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Adenocarcinoma of Colon | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
| ||
| Breast Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
| ||
| Breast Cancer Metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
| ||
| Altered State of Consciousness | Nervous system disorders | Non-systematic Assessment |
| ||
| Cerebral Haematoma | Nervous system disorders | Non-systematic Assessment |
| ||
| Cerebral Haemorrhage | Nervous system disorders | Non-systematic Assessment |
| ||
| Cerebrovascular Accident | Nervous system disorders | Non-systematic Assessment |
| ||
| Hydrocephalus | Nervous system disorders | Non-systematic Assessment |
| ||
| Loss of Consciousness | Nervous system disorders | Non-systematic Assessment |
| ||
| Syncope | Nervous system disorders | Non-systematic Assessment |
| ||
| Transient Ischaemic Attack | Nervous system disorders | Non-systematic Assessment |
| ||
| Abnormal Behaviour | Psychiatric disorders | Non-systematic Assessment |
| ||
| Agitation | Psychiatric disorders | Non-systematic Assessment |
| ||
| Completed Suicide | Psychiatric disorders | Non-systematic Assessment |
| ||
| Confusional State | Psychiatric disorders | Non-systematic Assessment |
| ||
| Delirium | Psychiatric disorders | Non-systematic Assessment |
| ||
| Mental Status Changes | Psychiatric disorders | Non-systematic Assessment |
| ||
| Paranoia | Psychiatric disorders | Non-systematic Assessment |
| ||
| Renal Failure | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Urinary Retention | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Vaginal Haemorrhage | Reproductive system and breast disorders | Non-systematic Assessment |
| ||
| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Pulmonary Oedema | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | Non-systematic Assessment |
| ||
| Urinary tract infection | Infections and infestations | Non-systematic Assessment |
| ||
| Agitation | Psychiatric disorders | Non-systematic Assessment |
| ||
| Anxiety | Psychiatric disorders | Non-systematic Assessment |
| ||
| Depression | Psychiatric disorders | Non-systematic Assessment |
| ||
| Dizziness | Nervous system disorders | Non-systematic Assessment |
| ||
| Headache | Nervous system disorders | Non-systematic Assessment |
| ||
| Diarrhoea | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Vomiting | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Weight decreased | Investigations | Non-systematic Assessment |
| ||
| Fall | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Project Manager | FUJIFILM Toyama Chemical | +81-3-6427-6245 | fftc-clinicaltrial-info1@fujifilm.com |
| Jul 12, 2018 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Heterozygotes |
|
| Homozygotes |
|
| Unknown |
|
Placebo once daily Placebo: Placebo |
|
|
|
| Participants |
|
|
|