| January 21, 2008 |
| January 21, 2008 |
| April 2008 |
| December 2008 (final data collection date for primary outcome measure) |
- Adverse Events [ Time Frame: 4-weeks ] [ Designated as safety issue: Yes ]
- Alzheimer's Disease Assessment Scale [ Time Frame: 4-weeks post dose ] [ Designated as safety issue: No ]
- Clinician's Interview Based Impression of Change [ Time Frame: 4-weeks post dose ] [ Designated as safety issue: No ]
|
| Same as current |
| No Changes Posted |
- Alzheimer's Disease Assessment Scale [ Time Frame: 24, 48, and 72 hrs post dose ] [ Designated as safety issue: No ]
- Clinician's Interview Based Impression of Change [ Time Frame: 24, 48, and 72 hrs post dose ] [ Designated as safety issue: No ]
- Clinical Dementia Rating Battery [ Time Frame: 24, 48, and 72 hrs post dose and 4-weeks post dose ] [ Designated as safety issue: No ]
- Alzheimer's Disease Cooperative Study - Activities of Daily Living [ Time Frame: 24, 48, and 72 hrs post dose and 4-weeks post dose ] [ Designated as safety issue: No ]
- Severe Impairment Battery [ Time Frame: 24, 48, and 72 hrs post dose and 4-weeks post dose ] [ Designated as safety issue: No ]
- Hopkins Verbal Learning Test-Revised [ Time Frame: 24, 48, and 72 hrs post dose and 4-weeks post dose ] [ Designated as safety issue: No ]
- Temperature [ Time Frame: 48 hrs and 4-weeks post dose ] [ Designated as safety issue: Yes ]
- Respiratory rate [ Time Frame: 48 hrs and 4-weeks post dose ] [ Designated as safety issue: Yes ]
- Blood pressure [ Time Frame: 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 ] [ Designated as safety issue: Yes ]
- Heart rate [ Time Frame: 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 ] [ Designated as safety issue: Yes ]
- Electrocardiogram [ Time Frame: 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 ] [ Designated as safety issue: Yes ]
- Physical Exam [ Time Frame: 48 hrs and 4-weeks post dose ] [ Designated as safety issue: Yes ]
- Hematology [ Time Frame: 48 hrs and 4-weeks post dose ] [ Designated as safety issue: Yes ]
- Blood chemistry [ Time Frame: 48 hrs and 4-weeks post dose ] [ Designated as safety issue: Yes ]
- Urinalysis [ Time Frame: 48 hrs and 4-weeks post dose ] [ Designated as safety issue: Yes ]
- Pharmacokinetics [ Time Frame: 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 ] [ Designated as safety issue: No ]
- Protein kinase C activity (pharmacodynamics) [ Time Frame: 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 ] [ Designated as safety issue: No ]
|
| Same as current |
| |
| Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics Study of Bryostatin 1 in Patients With Alzheimer's Disease |
| A Randomized, Double-Blind, Placebo-Controlled, Parallel Groups, Study to Evaluate the Safety, Efficacy, Pharmacokinetics and Pharmacodynamics of Bryostatin 1 in Patients With Mild to Moderate Alzheimer's Disease |
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. |
| |
| Phase II |
| Interventional |
| Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Alzheimer's Disease |
- Drug: Bryostatin for Injection
- Drug: Placebo
|
| |
| |
| |
| Not yet recruiting |
| 9 |
| December 2008 |
| December 2008 (final data collection date for primary outcome measure) |
Inclusion Criteria:
- Male or female, age 50 yrs or older. Females must be of non-childbearing potential (surgically sterilized or at least 2 yrs post-menopausal)
- Must have a cognitive deficit present for at least 1 yr & meet DSM-IV-TRTM criteria for AD & meet NINCDS/ADRDA criteria for the presence of probable AD
- Severity of AD must be mild to moderate, documented with a MMSE score of 12-26
- Has a CT scan or MRI scan within the prior 12 months, which is compatible with a diagnosis of probable AD
- Ability to walk, at least with an assistive device
- Vision & hearing sufficient to comply with testing
- Normal cognitive & social functioning prior to onset of dementia
- Consistent caregiver to accompany patient to assessment visits
- Sufficient basic education to be able to complete the cognitive assessments
- Living outside an institution
- Informed consent signed & dated by patient or legal representative
- Has provided written authorization for the use & disclosure of protected health information
Exclusion Criteria:
- Dementia due to any condition other than AD, including vascular dementia (modified Hachinski Ischemic Scale ≥ 5; positive NINDS-AIREN criteria)
- Evidence of clinically significant unstable cardiovascular, renal, hepatic, gastrointestinal, neurological, or metabolic disease within the past 6 months (as determined by medical history, ECG results, chest x-ray, or physical examination)
- Use of any drug within 14 days prior to randomization unless the dose of the drug & the condition being treated have been stable for at least 30 days & are expected to remain stable during the study & neither the drug nor the condition being treated is expected to interfere with the study endpoints
- Any medical or psychiatric condition that may require medication or surgical treatment during the study
- Life expectancy less than 6 months
- Any other screening laboratory values outside the normal ranges that are deemed clinically significant by the investigator
- Use of an investigational drug within 30 days prior to the screening visit or during the entire study
- Significant neurological disease other than AD, including cerebral tumor, Huntington's Disease, Parkinson's Disease, normal pressure hydrocephalus, & other entities
- Major depression according to DSM-IV
- Psychotic episodes requiring hospitalization or antipsychotic therapy for more than 2 weeks within the past 10 yrs, not linked to AD
- Agitation sufficient to preclude participation in this trial
- Alcohol or drug dependence diagnosed within the past 10 yrs
- Epilepsy or anti-epileptic drug therapy
- Abnormal laboratory tests that might point to another etiology for dementia: serum B12, folate, thyroid functions, electrolytes, syphilis serology
- Musculoskeletal diseases that could interfere with assessment
- Acute or poorly controlled medical illness: blood pressure> 180 mmHg systolic or 100 mmHg diastolic; myocardial infarction within 6 months; uncompensated congestive heart failure (NYHA Class III or IV), severe renal, hepatic or gastrointestinal disease that could alter drug pharmacokinetics; blood glucose > 180 mg/dl on repeated testing at entry into study or need for insulin therapy
- Previous randomization in this trial or participation in another investigational trial < 2 months prior to randomization
- Likelihood, according to clinical judgment, of being transferred to a nursing home within 6 months
- Change in dosage of any concomitant antidepressant within 30 days prior to randomization
- Lack of caregiver
- Pregnant or lactating females
- Patients who in the judgment of the Investigator may be unreliable or uncooperative with the evaluation procedures outlined in this protocol
- HIV positive
- Hepatitis B or C positive
- Concomitant use of medications other than AD or antidepressant medications for which the dose regimens are stabilized for at least 30 days prior to enrollment in study
|
| Both |
| 50 Years and older |
| No |
|
| United States |
| |
| NCT00606164 |
| Mark A. Cochran, Ph.D./CEO and Executive Director, Blanchette Rockefeller Neurosciences Insitute |
| BRY-201 |
| Blanchette Rockefeller Neurosciences Insitute |
|
| Principal Investigator: |
James M Stevenson, MD |
West Virginia University Department of Behavioral Medicine and Psychiatry |
|
|
| Blanchette Rockefeller Neurosciences Insitute |
| January 2008 |