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The main purpose of this study is find out how safe a single dose of bryostatin 1 is in patients with Alzheimer's Disease (AD). This study is also being done 1) to determine how effective a single dose of bryostatin 1 is in the treatment of AD, 2) to find out what happens to bryostatin 1 once it enters the body by measuring the levels of bryostatin 1 in blood, and 3) to measure a substance in the blood (protein kinase C) that may help to better understand how bryostatin 1 works.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator |
| |
| 10 ug/m2 Bryostatin | Experimental |
| |
| 15 ug/m2 Bryostatin | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bryostatin for Injection | Drug | A single one-hour intravenous infusion of 10 or 15 ug/m2 Bryostatin for Injection on Day 1 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | 4-weeks | |
| Alzheimer's Disease Assessment Scale | 4-weeks post dose | |
| Clinician's Interview Based Impression of Change | 4-weeks post dose |
| Measure | Description | Time Frame |
|---|---|---|
| Alzheimer's Disease Assessment Scale | 24, 48, and 72 hrs post dose | |
| Clinician's Interview Based Impression of Change | 24, 48, and 72 hrs post dose | |
| Clinical Dementia Rating Battery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| James M Stevenson, MD | West Virginia University Department of Behavioral Medicine and Psychiatry | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chestnut Ridge Center West Virginia University Department of Behavioral Medicine and Psychiatry | Morgantown | West Virginia | 26505 | United States |
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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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| ID | Term |
|---|---|
| D054713 | Bryostatins |
| D007267 | Injections |
| C046785 | bryostatin 1 |
| C062942 | 2-phenyl-6-(2'-(4'-(ethoxycarbonyl)thiazolyl))thiazolo(3,2-b)(1,2,4)triazole |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D000095702 | Polyether Toxins |
| D000095662 | Polyether Polyketides |
| D004988 | Ethers, Cyclic |
| D004987 | Ethers |
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|
| Placebo | Drug | A single one-hour intravenous infusion of placebo on Day 1 |
|
|
| 24, 48, and 72 hrs post dose and 4-weeks post dose |
| Alzheimer's Disease Cooperative Study - Activities of Daily Living | 24, 48, and 72 hrs post dose and 4-weeks post dose |
| Severe Impairment Battery | 24, 48, and 72 hrs post dose and 4-weeks post dose |
| Hopkins Verbal Learning Test-Revised | 24, 48, and 72 hrs post dose and 4-weeks post dose |
| Temperature | 48 hrs and 4-weeks post dose |
| Respiratory rate | 48 hrs and 4-weeks post dose |
| Blood pressure | 15, 30, and 60 minutes after start of study drug infusion, and at 1, 2, 4, 8, 12, 24, 48, and 72 hrs post infusion and 4-weeks post infusion |
| Heart rate | 15, 30, and 60 minutes after start of study drug infusion, and at 1, 2, 4, 8, 12, 24, 48, and 72 hrs post infusion and 4-weeks post infusion |
| Electrocardiogram | 15, 30, and 60 minutes after start of study drug infusion, and at 1, 2, 4, 8, 12, and 24 hrs post infusion and 4-weeks post infusion |
| Physical Exam | 48 hrs and 4-weeks post dose |
| Hematology | 48 hrs and 4-weeks post dose |
| Blood chemistry | 48 hrs and 4-weeks post dose |
| Urinalysis | 48 hrs and 4-weeks post dose |
| Pharmacokinetics | Blood draws at baseline, during the study drug infusion (15, 30, and 60 minutes after start of infusion), and at 20 minutes, 1 hr, 2 hrs, 6 hrs, 24 hrs, 48 hrs, and 72 hrs post infusion |
| Protein kinase C activity (pharmacodynamics) | Blood draws at baseline, during the study drug infusion (15, 30, and 60 minutes after start of infusion), and at 20 minutes, 1 hr, 2 hrs, 6 hrs, 24 hrs, 48 hrs, and 72 hrs post infusion |
| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D009930 |
| Organic Chemicals |
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D008387 | Marine Toxins |
| D014118 | Toxins, Biological |
| D001685 | Biological Factors |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |