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The purpose of this study is to investigate efficacy and safety of different doses of AC-3933 in patients with mild to moderate Alzheimer's Disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AC-3933 | Experimental | AC-3933, 5mg twice daily |
|
| AC-3933, 20 mg twice daily | Experimental | AC-3933, 20 mg twice daily |
|
| Placebo | Placebo Comparator | Sugar Pill twice daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AC-3933 | Drug | 5mg twice daily |
| |
| AC-3933 |
| Measure | Description | Time Frame |
|---|---|---|
| Total Score of Alzheimer's Disease Assessment Scale - Cognition Subscale (ADAS-COG)From Best Total Score (0) to Worst Total Score (70) | Change from baseline to week 16 of the double blind treatment in the Alzheimer's Disease Assessment Scale - Cognition Subscale (ADAS-COG) total score The Alzheimer's Disease Assessment Scale if used for assessing the severity of dysfuncion and for research in patients with AD, particularly in clinical drug trials. It consists of 11 items testing orientatin, memory, word usage and recognition, receptive speech, spatial abilities, ideational praxis, ability to follow instructions, spontanious speech abilities, and comprehension. The higher the overall score (maximum 70), the more severe the dysfunction/impairment. | Baseline to 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Clinicians Interview Based Impression of Change (CIBIC)-Plus | Clinicians Interview Based Impression of Change (CIBIC)-Plus-Plus scores at week 16 of the double blind treatment. CIBIC-Plus is ranged between 1 and 7 (1=very much improved, 4=no change, and 7=very much worsened). We were expecting smaller value of CIBIC-Plus at the study end. | Baseline to 16 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director, MD | Sumitomo Pharma America, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Trials Inc. | LIttle Rock | Alaska | 72205 | United States | ||
| PsyPharma Clinical Research Inc. |
17 patients were excluded from analysis because of QA issues at a study site.
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| ID | Title | Description |
|---|---|---|
| FG000 | AC-3933, 5 mg | AC-3933, 5mg twice daily |
| FG001 | AC-3933, 20 mg | AC-3933, 20 mg twice daily |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Drug |
AC-3933, 20 mg twice daily |
|
| Sugar Pill | Other | Sugar Pill twice daily |
|
|
| Disability Assessment for Dementia (DAD) | Change from baseline to week 16 of the double blind treatment in the Disability Assessment for Dementia (DAD) scores. The DAD is administered as a clinician-assisted interview with the caregiver and was developed to assess functional abilities in ADLs in community-dwelling dementia patients. The scale consists of 40 questions assessing basic and instumental ADLs. A total score is obtained by adding the rating for each question and converting this total score out of 100. The items rated N/A are not considered for the total score. Higher scores represent less disability in activities of daily living (ADL) while lower scores indicate more dysfunction. | Baseline to 16 Weeks |
| Phoenix |
| Arizona |
| 85013 |
| United States |
| ClinicalStudies Center LLC | Little Rock | Arkansas | 72205 | United States |
| Vertex Clinical Research | Bakersfield | California | 93311 | United States |
| East Bay Physicians Medical Grou[ | Berkeley | California | 94705 | United States |
| Margolin Brain Institute | Fresno | California | 93720 | United States |
| Clinical Trials Associates | Mission Viejo | California | 92691 | United States |
| University of California | Orange | California | 92868 | United States |
| Pacific Research Network | San Diego | California | 92103 | United States |
| Memory Disorder Clinic | Deerfield Beach | Florida | 33064 | United States |
| Berma Research Group | Hialeah | Florida | 33016 | United States |
| Advanced Research Institute of Miami | Miami | Florida | 33135 | United States |
| Research Institute of Miami | Miami | Florida | 33135 | United States |
| Research Center of Florida Inc. | Miami | Florida | 33173 | United States |
| Medical Research Group of Central Florida | Orange City | Florida | 32763 | United States |
| Compass Research LLC | Orlando | Florida | 32806 | United States |
| Department of Psychiatry and Behavioral Medicine | Tampa | Florida | 33613 | United States |
| Stedman Clinical Trials LLC | Tampa | Florida | 33613 | United States |
| Four Rivers Clinical Research Inc. | Paducah | Kentucky | 42003 | United States |
| Northern Michigan Neurology | Traverse City | Michigan | 49684 | United States |
| Minneapolis | Minnesota | 53454 | United States |
| Clinical Psychopharmacology Consultants PA | Saint Louis Park | Minnesota | 55416 | United States |
| Precise Research Centers INc. | Flowood | Mississippi | 37232 | United States |
| Psych Care Consultants Research | St Louis | Missouri | 63128 | United States |
| Odyssey Researcfh | Fargo | North Dakota | 58104 | United States |
| Paradigm Research Professionals LLP | Oklahoma City | Oklahoma | 73112 | United States |
| Cutting Edge Research Group | Oklahoma City | Oklahoma | 73116 | United States |
| Tulsa Clinical Research LLC | Tulsa | Oklahoma | 74104 | United States |
| The Clinical Trial Center | Jenkintown | Pennsylvania | 19046 | United States |
| UT Medical Group Inc. | Memphis | Tennessee | 38105 | United States |
| Neurological Research Center, Inc. | Bennington | Vermont | 05201 | United States |
| International Clinical Research Associates LLC | Richmond | Virginia | 23229 | United States |
| The Center for Excellence in Aging and Geriatric Health | Williamsburg | Virginia | 23185 | United States |
| Internal Medicine Northwest | Tacoma | Washington | 98405 | United States |
| FG002 |
| Placebo |
Sugar Pill twice daily |
| COMPLETED |
|
| NOT COMPLETED |
|
132 subjects were from the full analysis set, which was defined as all randomized subjects who took at least one dose of study drug and had greater than/equal to one post-baseline ADAS-Cog assessment
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| ID | Title | Description |
|---|---|---|
| BG000 | AC-3933 | AC-3933, 5mg twice daily |
| BG001 | AC-3933, 20 mg | AC-3933, 20 mg twice daily |
| BG002 | Placebo | Sugar Pill twice daily |
| 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, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Age Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | 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 | Total Score of Alzheimer's Disease Assessment Scale - Cognition Subscale (ADAS-COG)From Best Total Score (0) to Worst Total Score (70) | Change from baseline to week 16 of the double blind treatment in the Alzheimer's Disease Assessment Scale - Cognition Subscale (ADAS-COG) total score The Alzheimer's Disease Assessment Scale if used for assessing the severity of dysfuncion and for research in patients with AD, particularly in clinical drug trials. It consists of 11 items testing orientatin, memory, word usage and recognition, receptive speech, spatial abilities, ideational praxis, ability to follow instructions, spontanious speech abilities, and comprehension. The higher the overall score (maximum 70), the more severe the dysfunction/impairment. | Posted | Apr 2010 | Mean | Standard Deviation | units on a scale | Baseline to 16 weeks |
|
|
| |||||||||||||||||||||||||||||||
| Secondary | Clinicians Interview Based Impression of Change (CIBIC)-Plus | Clinicians Interview Based Impression of Change (CIBIC)-Plus-Plus scores at week 16 of the double blind treatment. CIBIC-Plus is ranged between 1 and 7 (1=very much improved, 4=no change, and 7=very much worsened). We were expecting smaller value of CIBIC-Plus at the study end. | Posted | Apr 2010 | Mean | Standard Deviation | units on a scale | Baseline to 16 weeks |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Disability Assessment for Dementia (DAD) | Change from baseline to week 16 of the double blind treatment in the Disability Assessment for Dementia (DAD) scores. The DAD is administered as a clinician-assisted interview with the caregiver and was developed to assess functional abilities in ADLs in community-dwelling dementia patients. The scale consists of 40 questions assessing basic and instumental ADLs. A total score is obtained by adding the rating for each question and converting this total score out of 100. The items rated N/A are not considered for the total score. Higher scores represent less disability in activities of daily living (ADL) while lower scores indicate more dysfunction. | Posted | Apr 2010 | Mean | Standard Deviation | units on a scale | Baseline to 16 Weeks |
|
|
February 2006 to September 2008
The AE summary was based on the safety population, which was defined as all randomized patients who received at least one dose of the study drug (58 placebo, 50 AC-3933 5mg, 46 AC-3933 20mg. Once subject randomized to AC-3933 20mg group received placebo during the course of the study. So this subject was summarized in the placebe group.
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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 | AC-3933, 5 mg | AC-3933, 5mg twice daily | 5 | 50 | 11 | 50 | ||
| EG001 | AC-3933, 20 mg | AC-3933, 20 mg twice daily | 4 | 46 | 12 | 46 | ||
| EG002 | Placebo | Sugar Pill twice daily | 5 | 58 | 17 | 58 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac Failure congestive | Cardiac disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Cardiomyopathy | Cardiac disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Abdominal Mass | Gastrointestinal disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Bronchitis acute | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Eye Injury | Injury, poisoning and procedural complications | MedDRA (9.0) | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (9.0) | Non-systematic Assessment |
| |
| Rib Fracture | Injury, poisoning and procedural complications | MedDRA (9.0) | Non-systematic Assessment |
| |
| Blood Pressure Increased | Investigations | MedDRA (9.0) | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Colon Cancer stage IV | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (9.0) | Systematic Assessment |
| |
| Metastases to liver | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (9.0) | Systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (9.0) | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Abnormal Behavior | Psychiatric disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anxiety | Psychiatric disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Urinary Tract infection | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Electroencephalogram abnormal | Investigations | MedDRA (9.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director, CNS | Sunovion | 1-866-503-6351 |
| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| D003704 | Dementia |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C483032 | 5-(3-methoxyphenyl)-3-(5-methyl-1,2,4-oxadiazol-3-yl)-2-oxo-1,2-dihydro-1,6-naphthyridine |
| D000073893 | Sugars |
| ID | Term |
|---|---|
| D002241 | Carbohydrates |
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| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
|
| Participants |
|
|