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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-024270-19 | EudraCT Number |
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To evaluate the safety and tolerability of ascending oral doses of CHF 5074 administered once per day for up to 12 weeks 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 |
|
| Placebo | Placebo Comparator | placebo, 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 12 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Differences in ∆sCD40L Levels Between CHF 5074 Doses and Placebo at Any Specific Time Point | To assess if there were differences in ΔsCD40L levels between CHF 5074 doses and placebo | up to 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Measurement of Trough CHF 5074 Plasma Levels | evaluate the pharmacokinetics (PK) of CHF 5074 in patients with MCI. | Days 85 |
| Changes in Plasma ΔTNFα Concentrations | 29 days |
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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 |
|---|---|---|---|---|---|---|
| Comprehensive NeuroScience, Inc. | St. Petersburg | Florida | 33716 | United States | ||
| Memory Enhancement Center of America, Inc. |
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| ID | Title | Description |
|---|---|---|
| FG000 | CHF 5074 1x | oral tablet, multidose CHF 5074 1x: oral tablet, 1x, once a day in the morning for 12 weeks |
| FG001 | CHF 5074 2x | oral tablet, multidose CHF 5074 2x: oral tablet, 1x, once a day in the morning for 4 weeks, followed by oral tablet, 2x, once a day in the morning for 8 weeks |
| FG002 | CHF 5074 3x | oral tablet, multidose CHF 5074 3x: 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 4 weeks |
| FG003 | Placebo | placebo, oral tablet, multidose Placebo: oral tablet, once a day in the morning for 12 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | CHF 5074 1x | oral tablet, multidose CHF 5074 1x: oral tablet, 1x, once a day in the morning for 12 weeks |
| BG001 | CHF 5074 2x | oral tablet, multidose CHF 5074 2x: oral tablet, 1x, once a day in the morning for 4 weeks, followed by oral tablet, 2x, once a day in the morning for 8 weeks |
| 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 | Differences in ∆sCD40L Levels Between CHF 5074 Doses and Placebo at Any Specific Time Point | To assess if there were differences in ΔsCD40L levels between CHF 5074 doses and placebo | ITT | Posted | Mean | Standard Error | pg/ml | up to 12 weeks |
|
Trial duration
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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 | CHF 5074 1x | oral tablet, multidose CHF 5074 1x: oral tablet, 1x, once a day in the morning for 12 weeks |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| intestinal obstruction | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| diarrhoea | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Richard Margolin | Cerespir | (646) 202-2562 | rmargolin@cerespir.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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| 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 8 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 4 weeks |
|
| Placebo | Drug | oral tablet, once a day in the morning for 12 weeks |
|
| Eatontown |
| New Jersey |
| 07724 |
| United States |
| Memory Center of New Jersey, Inc. | 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. Maggiore Policlinico, Clin. Neurol | Milan | Italy |
| Osp. Niguarda Ca'Granda, Dip. Di Neuroscienze | Milan | Italy |
| Nuovo Osp Civ S. Agostino Estense, Dip di Neuroscienze | Modena | Italy |
| BG002 | CHF 5074 3x | oral tablet, multidose CHF 5074 3x: 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 4 weeks |
| BG003 | Placebo | placebo, oral tablet, multidose Placebo: oral tablet, once a day in the morning for 12 weeks |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 |
| CHF 5074 3x |
oral tablet, multidose CHF 5074 3x: 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 4 weeks |
| OG003 | Placebo | placebo, oral tablet, multidose Placebo: oral tablet, once a day in the morning for 12 weeks |
|
|
| Secondary | Measurement of Trough CHF 5074 Plasma Levels | evaluate the pharmacokinetics (PK) of CHF 5074 in patients with MCI. | Posted | Mean | Standard Deviation | ng/ml | Days 85 |
|
|
|
| Secondary | Changes in Plasma ΔTNFα Concentrations | ITT | Posted | Mean | Standard Error | pg/ml | 29 days |
|
|
|
| 2 |
| 24 |
| 9 |
| 24 |
| EG001 | CHF 5074 2x | oral tablet, multidose CHF 5074 2x: oral tablet, 1x, once a day in the morning for 4 weeks, followed by oral tablet, 2x, once a day in the morning for 8 weeks | 2 | 24 | 18 | 24 |
| EG002 | CHF 5074 3x | oral tablet, multidose CHF 5074 3x: 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 4 weeks | 1 | 24 | 11 | 24 |
| EG003 | Placebo | placebo, oral tablet, multidose Placebo: oral tablet, once a day in the morning for 12 weeks | 1 | 24 | 7 | 24 |
| Acute congestive heart failure | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
|
| cardiac failure congestive | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
|
| bronchitis | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| cerebrovascular accident | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
|
| penis carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.0) | Systematic Assessment |
|
| femur fracture | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Systematic Assessment |
|
| adenocarcinoma f transverse colon | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.0) | Systematic Assessment |
|
| back pain | Metabolism and nutrition disorders | MedDRA (11.0) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
|
| headache | General disorders | MedDRA (11.0) | Systematic Assessment |
|
| nausea | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
|
| vomiting | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| nasopharyngitis | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Systematic Assessment |
|
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| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |