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This is a Phase II, Single-Blind, Placebo-Controlled, Sequential Treatment, Multiple Ascending Dose Study to Evaluate the Safety and Tolerability of CPC-201 in Patients with Alzheimer's Disease Type Dementia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CPC-201 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CPC-201 | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Donepezil Maximum Tolerated Dose (MTD) | Number of participants who reached Donepezil Maximum Tolerated Dose of 40 mg/day (highest allowed per protocol) at the end of donepezil dose titration phase and at the end of the maintenance phase. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Any TEAEs | Number of subjects who experienced any treatment-emergent adverse events (TEAEs) at any time during the study. | 6 months |
| Donepezil Plasma Concentration at Maximum Tolerated (MTD) or Maximum Allowable Dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lynn James | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CPC1 | West Palm Beach | Florida | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Solifenacin Dose Escalation | Solifenacin upward dose titration from 10 mg/day to 15 mg/day (together with donepezil 10 mg/day) |
| FG001 | Donepezil Dose Escalation | Donepezil upward dose titration up to the first intolerable dose (FID) or up to 40 mg/kg together with solifenacin 15 mg/day. End of dose escalation phase. |
| FG002 | Donepezil Dose Maintenance | Donepezil upward dose titration up to the first intolerable dose (FID) or up to 40 mg/kg together with solifenacin 15 mg/day. End of Dose Maintenance phase. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Solifenacin Dose Escalation Phase |
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| |||||||||||||||||||||
| Donepezil Dose Escalation Phase |
| ||||||||||||||||||||||
| Donepezil Dose Maintenance Phase |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Safety Population | All subjects who received at least one dose of any study drug. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Donepezil Maximum Tolerated Dose (MTD) | Number of participants who reached Donepezil Maximum Tolerated Dose of 40 mg/day (highest allowed per protocol) at the end of donepezil dose titration phase and at the end of the maintenance phase. | Posted | Number | Participants | 6 months |
|
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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 | Safety Population | All subjects who received at least one dose of any study drug. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA, Version 18.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhea | Gastrointestinal disorders | MedDRA, Version 18.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Area Head | Allergan, Inc | 714-246-4500 | clinicaltrials@allergan.com |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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Donepezil Plasma Concentration pre-dose and 4 hour post-dose at Maximum Tolerated (MTD) or Maximum Allowable Dose, measured at baseline, at end of donepezil dose titration and at the end of maintenance.
| Day 1 (baseline) to end of study |
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| NOT COMPLETED |
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| Years |
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| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| Secondary | Number of Subjects With Any TEAEs | Number of subjects who experienced any treatment-emergent adverse events (TEAEs) at any time during the study. | All subjects those who received at least one dose of any study drug. | Posted | Number | Participants | 6 months |
|
|
|
| Secondary | Donepezil Plasma Concentration at Maximum Tolerated (MTD) or Maximum Allowable Dose | Donepezil Plasma Concentration pre-dose and 4 hour post-dose at Maximum Tolerated (MTD) or Maximum Allowable Dose, measured at baseline, at end of donepezil dose titration and at the end of maintenance. | Posted | Mean | Standard Deviation | ng/mL | Day 1 (baseline) to end of study |
|
|
|
| 8 |
| 41 |
| 33 |
| 41 |
| Pelvic fracture | Injury, poisoning and procedural complications | MedDRA, Version 18.1 | Systematic Assessment |
|
| Urosepsis | Infections and infestations | MedDRA, Version 18.1 | Systematic Assessment |
|
| Gastric volvulus | Gastrointestinal disorders | MedDRA, Version 18.1 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA, Version 18.1 | Systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA, Version 18.1 | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA, Version 18.1 | Systematic Assessment |
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| Agitation | Nervous system disorders | MedDRA, Version 18.1 | Systematic Assessment |
|
| Acute myocardial infarction | Cardiac disorders | MedDRA, Version 18.1 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA, Version 18.1 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA, Version 18.1 | Systematic Assessment |
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| Abdominal discomfort | Gastrointestinal disorders | MedDRA, Version 18.1 | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA, Version 18.1 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA, Version 18.1 | Systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | MedDRA, Version 18.1 | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA, Version 18.1 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA, Version 18.1 | Systematic Assessment |
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| Tremor | Nervous system disorders | MedDRA, Version 18.1 | Systematic Assessment |
|
A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
|