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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-004299-20 | EudraCT Number |
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| Name | Class |
|---|---|
| Elan Pharmaceuticals | INDUSTRY |
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The primary purpose of this study is to determine whether ELND005 is effective in treating symptoms of agitation and aggression in patients with Alzheimer's disease
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ELND005 | Experimental | ELND005 film coated tablets, BID for 12 weeks |
|
| Placebo | Placebo Comparator | Matched placebo BID for 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ELND005 | Drug |
|
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in NPI-C Combined Agitation and Aggression Subscores (NPI-C A+A). | The NPI-C (de Medeiros et al 2010) is a validated and reliable behavioral measure that assesses psychopathology in dementia subjects. It evaluates 14 neuropsychiatric disturbances common in dementia.Higher scores on the NPI-C are associated with a greater clinical severity of symptoms. The NPI-C Agitation and Aggression score ranges from 0-63. The analysis of the NPI-C A+A score was performed on the mITT population. | Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Modified-ADCS-CGIC Agitation Scores | The Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC) is a widely used scale for the global assessment of change in AD trials.It is a 7-point Likert scale that ranges from marked improvement scored as 1 to marked worsening scored as 7, with no change scored as 4. The range is from 1 to 7. Higher scores indicate worsening agitation. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| TransitionTIL Investigational Site | Birmingham | Alabama | 35294 | United States | ||
| TransitionTIL Investigational Site |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | ELND005 | ELND005 film coated tablets, BID for 12 weeks ELND005 |
| FG001 | Placebo | Matched placebo BID for 12 weeks Placebo |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
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| Drug |
|
| Week 12 |
| Change From Baseline in NPI Total Scores | The NPI (Cummings et al 1994) is a behavioral measure that assesses psychopathology in dementia subjects. It evaluates 12 neuropsychiatric disturbances common in dementia: delusions, hallucinations, agitation/aggression, dysphoria, anxiety, apathy, irritability, euphoria, disinhibition, aberrant motor behavior, nighttime behavior disturbances, and appetite and eating abnormalities. Higher scores on the NPI are associated with greater frequency and severity of symptoms. The scale range is 0-144. | Week 12 |
| Change From Baseline in MMSE Scores | The Mini-Mental State Exam (MMSE) (Folstein et al 1975) is a brief cognitive test assessing general cognitive function that has been employed in numerous clinical trials of products approved for the treatment of AD. The score can range from 0 to 30, with lower scores indicating greater impairment in function. | Week 12 |
| Change From Baseline in ADCS-ADL Scores | The Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) (Galasko et al 1997) is a functional assessment that measures instrumental and basic activities of daily living. The total score for the 23-item ADCS-ADL ranges from 0 to 78 points, with lower scores indicating greater impairment in function. | Week 12 |
| Phoenix |
| Arizona |
| 85004 |
| United States |
| TransitionTIL Investigational Site | Phoenix | Arizona | 85006 | United States |
| TransitionTIL Investigational Site | Encino | California | 91316 | United States |
| TransitionTIL Investigational Site | Escondido | California | 92025 | United States |
| TransitionTIL Investigational Site | Fresno | California | 93710 | United States |
| TransitionTIL Investigational Site | Irvine | California | 92697 | United States |
| TransitionTIL Investigational Site | Long Beach | California | 90806 | United States |
| TransitionTIL Investigational Site | Los Alamitos | California | 90720 | United States |
| TransitionTIL Investigational Site | Los Angeles | California | 90073 | United States |
| TransitionTIL Investigational Site | Newport Beach | California | 92663 | United States |
| TransitionTIL Investigational Site | Santa Ana | California | 92701 | United States |
| TransitionTIL Investigational Site | Norwalk | Connecticut | 06851 | United States |
| TransitionTIL Investigational Site | Washington D.C. | District of Columbia | 20057 | United States |
| TransitionTIL Investigational Site | Atlantis | Florida | 33462 | United States |
| TransitionTIL Investigational Site | Deerfield Beach | Florida | 33064 | United States |
| TransitionTIL Investigational Site | Delray Beach | Florida | 33445 | United States |
| TransitionTIL Investigational Site | Lake Worth | Florida | 33449 | United States |
| TransitionTIL Investigational Site | Miami | Florida | 33137 | United States |
| TransitionTIL Investigational Site | Oakland Park | Florida | 33334 | United States |
| TransitionTIL Investigational Site | Orlando | Florida | 32806 | United States |
| TransitionTIL Investigational Site | Ormond Beach | Florida | 32174 | United States |
| TransitionTIL Investigational Site | Port Charlotte | Florida | 33952 | United States |
| TransitionTIL Investigational Site | Sarasota | Florida | 34243 | United States |
| TransitionTIL Investigational Site | Sunrise | Florida | 33351 | United States |
| TransitionTIL Investigational Site | Columbus | Georgia | 31909 | United States |
| TransitionTIL Investigational Site | Savannah | Georgia | 31419 | United States |
| TransitionTIL Investigational Site | Springfield | Illinois | 62702 | United States |
| TransitionTIL Investigational Site | Bangor | Maine | 04402 | United States |
| TransitionTIL Investigational Site | Easton | Maryland | 21601 | United States |
| TransitionTIL Investigational Site | Winchester | Massachusetts | 01890 | United States |
| TransitionTIL Investigational Site | Ann Arbor | Michigan | 48105 | United States |
| TransitionTIL Investigational Site | Paw Paw | Michigan | 49079 | United States |
| TransitionTIL Investigational Site | Saint Paul | Minnesota | 55130 | United States |
| TransitionTIL Investigational Site | Hattiesburg | Mississippi | 39401 | United States |
| TransitionTIL Investigational Site | Stratford | New Jersey | 08084 | United States |
| TransitionTIL Investigational Site | Rochester | New York | 14620 | United States |
| TransitionTIL Investigational Site | Rochester | New York | 14623 | United States |
| TransitionTIL Investigational Site | Charlotte | North Carolina | 28209 | United States |
| TransitionTIL Investigational Site | Charlotte | North Carolina | 28211 | United States |
| TransitionTIL Investigational Site | Durham | North Carolina | 27710 | United States |
| TransitionTIL Investigational Site | Wilmington | North Carolina | 28401 | United States |
| TransitionTIL Investigational Site | Winston-Salem | North Carolina | 27103 | United States |
| TransitionTIL Investigational Site | Oklahoma City | Oklahoma | 73112 | United States |
| TransitionTIL Investigational Site | Portland | Oregon | 97225 | United States |
| TransitionTIL Investigational Site | Abington | Pennsylvania | 19001 | United States |
| TransitionTIL Investigational Site | Jenkintown | Pennsylvania | 19046 | United States |
| TransitionTIL Investigational Site | Norristown | Pennsylvania | 19401 | United States |
| TransitionTIL Investigational Site | Philadelphia | Pennsylvania | 19104 | United States |
| TransitionTIL Investigational Site | Philadelphia | Pennsylvania | 19107 | United States |
| TransitionTIL Investigational Site | Pittsburgh | Pennsylvania | 15213 | United States |
| TransitionTIL Investigational Site | North Charleston | South Carolina | 29406 | United States |
| TransitionTIL Investigational Site | Port Royal | South Carolina | 29935 | United States |
| TransitionTIL Investigational Site | Nashville | Tennessee | 37212 | United States |
| TransitionTIL Investigational Site | DeSoto | Texas | 75115 | United States |
| TransitionTIL Investigational Site | Richmond | Virginia | 23230 | United States |
| TransitionTIL Investigational Site | Bellevue | Washington | 98007 | United States |
| TransitionTIL Investigational Site | Calgary | Alberta | T2N-4Z6 | Canada |
| TransitionTIL Investigational Site | Kelowna | British Columbia | V1Y 3G8 | Canada |
| TransitionTIL Investigational Site | Toronto | Ontario | M4N 3M5 | Canada |
| TransitionTIL Investigational Site | Toronto | Ontario | M6M 3Z5 | Canada |
| TransitionTIL Investigational Site | Regina | Saskatchewan | S4T 1A5 | Canada |
| TransitionTIL Investigational Site | Elche | Alicante | 03203 | Spain |
| TransitionTIL Investigational Site | Getxo | Biscay | 48993 | Spain |
| TransitionTIL Investigational Site | Barcelona | 08029 | Spain |
| TransitionTIL Investigational Site | Barcelona | 08221 | Spain |
| TransitionTIL Investigational Site | Burgos | 09006 | Spain |
| TransitionTIL Investigational Site | Madrid | 28040 | Spain |
| TransitionTIL Investigational Site | Bath | BA1 3NG | United Kingdom |
| TransitionTIL Investigational Site | Swindon | SN3 6BW | United Kingdom |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | ELND005 | ELND005 film coated tablets, BID for 12 weeks ELND005 |
| BG001 | Placebo | Matched placebo BID for 12 weeks Placebo |
| BG002 | 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, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| 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 | Change From Baseline in NPI-C Combined Agitation and Aggression Subscores (NPI-C A+A). | The NPI-C (de Medeiros et al 2010) is a validated and reliable behavioral measure that assesses psychopathology in dementia subjects. It evaluates 14 neuropsychiatric disturbances common in dementia.Higher scores on the NPI-C are associated with a greater clinical severity of symptoms. The NPI-C Agitation and Aggression score ranges from 0-63. The analysis of the NPI-C A+A score was performed on the mITT population. | mITT | Posted | Mean | Standard Error | units on a scale | Week 12 |
|
|
| ||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Modified-ADCS-CGIC Agitation Scores | The Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC) is a widely used scale for the global assessment of change in AD trials.It is a 7-point Likert scale that ranges from marked improvement scored as 1 to marked worsening scored as 7, with no change scored as 4. The range is from 1 to 7. Higher scores indicate worsening agitation. | mITT population with available data for Modified-ADCS-CGIC Agitation Scores | Posted | Mean | Standard Error | units on a scale | Week 12 |
|
| |||||||||||||||||||||||||||||
| Secondary | Change From Baseline in NPI Total Scores | The NPI (Cummings et al 1994) is a behavioral measure that assesses psychopathology in dementia subjects. It evaluates 12 neuropsychiatric disturbances common in dementia: delusions, hallucinations, agitation/aggression, dysphoria, anxiety, apathy, irritability, euphoria, disinhibition, aberrant motor behavior, nighttime behavior disturbances, and appetite and eating abnormalities. Higher scores on the NPI are associated with greater frequency and severity of symptoms. The scale range is 0-144. | mITT population with available data for NPI Total Scores | Posted | Mean | Standard Error | units on a scale | Week 12 |
|
| |||||||||||||||||||||||||||||
| Secondary | Change From Baseline in MMSE Scores | The Mini-Mental State Exam (MMSE) (Folstein et al 1975) is a brief cognitive test assessing general cognitive function that has been employed in numerous clinical trials of products approved for the treatment of AD. The score can range from 0 to 30, with lower scores indicating greater impairment in function. | mITT population with available data for MMSE Scores | Posted | Mean | Standard Error | units on a scale | Week 12 |
|
| |||||||||||||||||||||||||||||
| Secondary | Change From Baseline in ADCS-ADL Scores | The Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) (Galasko et al 1997) is a functional assessment that measures instrumental and basic activities of daily living. The total score for the 23-item ADCS-ADL ranges from 0 to 78 points, with lower scores indicating greater impairment in function. | mITT population with available data for ADCS-ADL Scores | Posted | Mean | Standard Error | units on a scale | Week 12 |
|
|
Adverse events were recorded for each patient starting from the time the consent form was signed until the completion of the study
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ELND005 | ELND005 film coated tablets, BID for 12 weeks ELND005 | 17 | 175 | 97 | 175 | ||
| EG001 | Placebo | Matched placebo BID for 12 weeks Placebo | 5 | 175 | 82 | 175 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fall | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
| |
| Acetabulum fracture | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
| |
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
| |
| Pelvic fracture | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Urinary tract infection enterococcal | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Convulsion | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Cerebellar infarction | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (Unspecified) | Systematic Assessment |
| |
| Rectal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (Unspecified) | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Type 2 diabetes mellitus | Metabolism and nutrition disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Homocidal ideation | Psychiatric disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Psychotic disorder | Psychiatric disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Agitation | Psychiatric disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Lethargy | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Gait disturbance | General disorders | MedDRA (Unspecified) | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Aleksandra Pastrak, MD, PhD, Vice President Clinical Development | Transition Therapeutics Ireland Limited | +1 416 263 1227 | apastrak@transitiontherapeutics.com |
| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| D011595 | Psychomotor Agitation |
| D000374 | Aggression |
| 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 |
| D020820 | Dyskinesias |
| D009461 | Neurologic Manifestations |
| D011596 | Psychomotor Disorders |
| D019954 | Neurobehavioral Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000096762 | Aberrant Motor Behavior in Dementia |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D012919 | Social Behavior |
Not provided
Not provided
| ID | Term |
|---|---|
| C009217 | scyllitol |
Not provided
Not provided
Not provided
| >=65 years |
|
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| United States |
|
| United Kingdom |
|
| Spain |
|
|
|
|
|