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Glutamate is fundamentally involved in learning and memory. Memory loss associated with mild cognitive impairment may be due to loss of glutamate receptors in the aging brain. There is evidence CX516 enhances brain activity by specifically targeting remaining glutamate receptors in the affected portions of the brain. This study will test the safety and efficacy of CX516 in the symptomatic treatment of participants with mild cognitive impairment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CX516 | Experimental | CX516 - 900 mg |
|
| Placebo | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CX516 | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| 15-Item Word List Delayed Recall | The 15-Item Word List delayed recall score is used as a clinical measure of episodic memory, and was the primary outcome variable for this study. Episodic memory of the type addressed by delayed recall of lists and stories (i.e., in the WMS-R logical memory tests and 15-item World List recall tests) is among the earliest deficits during aging and MCI compared to other aspects of cognition (attention, reaction time, language, etc). It was decided to use the 15-item Word List delayed recall test as the primary outcome measure due to its sensitivity in the assessment of MCI. The possible score range for the 15-item Word List Delayed Recall test is 0 to 15. A clinical improvement of MCI or dementia would be characterized by an increase in the score due to an increase in the number of words recalled. | 28 Days |
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Inclusion criteria
Exclusion criteria
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pivotal Research Centers | Peoria | Arizona | 85381 | United States | ||
| University of California Irvine |
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| ID | Title | Description |
|---|---|---|
| FG000 | CX516 | CX516 - 900 mg CX516 (Ampalex®) |
| FG001 | Placebo | Placebo to CX516 900 mg CX516 (Ampalex®) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | CX516 | CX516 - 900 mg CX516 (Ampalex®) |
| BG001 | Placebo | Placebo to CX516 900 mg CX516 (Ampalex®) |
| 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 | 15-Item Word List Delayed Recall | The 15-Item Word List delayed recall score is used as a clinical measure of episodic memory, and was the primary outcome variable for this study. Episodic memory of the type addressed by delayed recall of lists and stories (i.e., in the WMS-R logical memory tests and 15-item World List recall tests) is among the earliest deficits during aging and MCI compared to other aspects of cognition (attention, reaction time, language, etc). It was decided to use the 15-item Word List delayed recall test as the primary outcome measure due to its sensitivity in the assessment of MCI. The possible score range for the 15-item Word List Delayed Recall test is 0 to 15. A clinical improvement of MCI or dementia would be characterized by an increase in the score due to an increase in the number of words recalled. | Intent to Treat (ITT) | Posted | Mean | Standard Deviation | units on a scale - change from baseline | 28 Days |
|
28 Day treatment 8 week followup
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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 | CX516 | CX516 - 900 mg (3 X 300 mg) CX516 (Ampalex®) | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| neutrophil count decrease | Blood and lymphatic system disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Pain | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Richard Purcell | RespireRx Pharmaceuticals | 732-492-1797 | rpurcell@respirerx.com |
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| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| D008569 | Memory Disorders |
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D019954 | Neurobehavioral Manifestations |
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| ID | Term |
|---|---|
| C097396 | 1-(quinoxalin-6-ylcarbonyl)piperidine |
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|
| Irvine |
| California |
| 92697 |
| United States |
| University of California at Los Angeles | Los Angeles | California | 90095 | United States |
| University of California, San Diego | San Diego | California | 92093 | United States |
| Yale University School of Medicine | New Haven | Connecticut | 06510 | United States |
| Sun Coast Gerontology Center, University of South Florida | Tampa | Florida | 33617 | United States |
| Mercy Mayo Clinic | Des Moines | Iowa | 50314 | United States |
| University of Pittsburgh | Pittsburgh | Pennsylvania | 15213 | United States |
| BG002 |
| Total |
Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
CX516 - 900 mg (3 X 300 mg) CX516 (Ampalex®) |
| OG001 | Placebo | Placebo to CX516 300 mg CX516 (Ampalex®) |
|
|
|
| 84 |
| 3 |
| 84 |
| 68 |
| 84 |
| EG001 | Placebo | Placebo to CX516 300 mg CX516 (Ampalex®) | 0 | 91 | 1 | 91 | 56 | 91 |
| moderate urinary tract infection | Infections and infestations | Systematic Assessment |
|
| angina pectoris | Cardiac disorders | Systematic Assessment |
|
| Chest pain | Cardiac disorders | Systematic Assessment |
|
| Fatigue | General disorders | Systematic Assessment |
|
| Urinary Tract Infections | Infections and infestations | Systematic Assessment |
|
| Creatinin increased | Investigations | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Dizziness | Nervous system disorders | Systematic Assessment |
|
| Insominia | Psychiatric disorders | Systematic Assessment |
|
| Pruritis | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | Systematic Assessment |
|
| Diarrhea NOS | Gastrointestinal disorders | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | Systematic Assessment |
|
| Eructation | Gastrointestinal disorders | Systematic Assessment |
|
| Flatulance | Gastrointestinal disorders | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| Pyrexia | General disorders | Systematic Assessment |
|
| Neutrophil decreased | Investigations | Systematic Assessment |
|
| back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Headache | Nervous system disorders | Systematic Assessment |
|
| Somnolence | Nervous system disorders | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
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| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |