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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-024270-19 | EudraCT Number |
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The purpose of this study is to evaluate the safety and tolerability of ascending oral doses of CHF 5074 after prolonged administration to patients with mild cognitive impairment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CHF 5074 1x | Experimental | oral tablet, multidose |
|
| CHF 5074 2x | Experimental | oral tablet, multidose |
|
| CHF 5074 3x | Experimental | oral tablet, multidose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CHF 5074 1x | Drug | oral tablet, 1x, once a day in the morning for 24 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Determine maximum tolerated dose of CHF 5074 after multiple oral once daily administration to patients with mild cognitive impairment | 24 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joel S. Ross, MD | Memory Enhancement Center of America, Inc. | Principal Investigator |
| Gabriella Bottini, Prof. | Osp. Niguarda Ca Granda | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memory Enhancement Center of America, Inc. | Eatontown | New Jersey | 07724 | United States | ||
| Memory Center of New Jersey, Inc. |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Oct 19, 2015 | |
| Reset | Nov 17, 2015 | |
| Release | Feb 5, 2016 |
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| CHF 5074 2x |
| Drug |
oral tablet, 1x, once a day in the morning for 4 weeks, followed by oral tablet, 2x, once a day in the morning for 20 weeks |
|
| CHF 5074 3x | Drug | oral tablet, 1x, once a day in the morning for 4 weeks, followed by oral tablet, 2x, once a day in the morning for 4 weeks, followed by oral tablet, 3x, once a day in the morning for 16 weeks |
|
| Monroe Twp |
| New Jersey |
| 08831 |
| United States |
| Memory Enhancement Center of NJ, Inc. | Toms River | New Jersey | 08755 | United States |
| Senior Adults Specialty Research | Austin | Texas | 78757 | United States |
| Clinica Santa Maria, Div Neurologia | Castellanza | Italy |
| Osp. Niguarda Ca'Granda, Dip. Di Neuroscienze | Milan | Italy |
| Unrelease | Yes |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Oct 19, 2015 | Nov 17, 2015 | |||
| Feb 5, 2016 | Yes |
| 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 |
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