Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics Study of Bryostatin 1 in Patients With Alzheimer's Disease
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ClinicalTrials.gov Identifier: NCT00606164 |
Recruitment Status : Unknown
Verified January 2008 by Blanchette Rockefeller Neurosciences Insitute.
Recruitment status was: Not yet recruiting
First Posted : February 1, 2008
Last Update Posted : February 1, 2008
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Alzheimer's Disease | Drug: Bryostatin for Injection Drug: Placebo | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 9 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | 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 |
Study Start Date : | April 2008 |
Estimated Primary Completion Date : | December 2008 |
Estimated Study Completion Date : | December 2008 |

Arm | Intervention/treatment |
---|---|
Placebo Comparator: Placebo |
Drug: Placebo
A single one-hour intravenous infusion of placebo on Day 1
Other Name: PET (60/30/10) diluent plus sodium chloride for injection |
Experimental: 10 ug/m2 Bryostatin |
Drug: Bryostatin for Injection
A single one-hour intravenous infusion of 10 or 15 ug/m2 Bryostatin for Injection on Day 1
Other Names:
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Experimental: 15 ug/m2 Bryostatin |
Drug: Bryostatin for Injection
A single one-hour intravenous infusion of 10 or 15 ug/m2 Bryostatin for Injection on Day 1
Other Names:
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- Adverse Events [ Time Frame: 4-weeks ]
- Alzheimer's Disease Assessment Scale [ Time Frame: 4-weeks post dose ]
- Clinician's Interview Based Impression of Change [ Time Frame: 4-weeks post dose ]
- Alzheimer's Disease Assessment Scale [ Time Frame: 24, 48, and 72 hrs post dose ]
- Clinician's Interview Based Impression of Change [ Time Frame: 24, 48, and 72 hrs post dose ]
- Clinical Dementia Rating Battery [ Time Frame: 24, 48, and 72 hrs post dose and 4-weeks post dose ]
- Alzheimer's Disease Cooperative Study - Activities of Daily Living [ Time Frame: 24, 48, and 72 hrs post dose and 4-weeks post dose ]
- Severe Impairment Battery [ Time Frame: 24, 48, and 72 hrs post dose and 4-weeks post dose ]
- Hopkins Verbal Learning Test-Revised [ Time Frame: 24, 48, and 72 hrs post dose and 4-weeks post dose ]
- Temperature [ Time Frame: 48 hrs and 4-weeks post dose ]
- Respiratory rate [ Time Frame: 48 hrs and 4-weeks post dose ]
- 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 ]
- 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 ]
- 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 ]
- Physical Exam [ Time Frame: 48 hrs and 4-weeks post dose ]
- Hematology [ Time Frame: 48 hrs and 4-weeks post dose ]
- Blood chemistry [ Time Frame: 48 hrs and 4-weeks post dose ]
- Urinalysis [ Time Frame: 48 hrs and 4-weeks post dose ]
- 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 ]
- 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 ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 50 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00606164
United States, West Virginia | |
Chestnut Ridge Center West Virginia University Department of Behavioral Medicine and Psychiatry | |
Morgantown, West Virginia, United States, 26505 | |
Contact: Eric Rankin, Ph.D. 304-293-5323 erankin@hsc.wvu.edu | |
Principal Investigator: James M Stevenson, MD |
Principal Investigator: | James M Stevenson, MD | West Virginia University Department of Behavioral Medicine and Psychiatry |
Responsible Party: | Mark A. Cochran, Ph.D./CEO and Executive Director, Blanchette Rockefeller Neurosciences Insitute |
ClinicalTrials.gov Identifier: | NCT00606164 |
Other Study ID Numbers: |
BRY-201 |
First Posted: | February 1, 2008 Key Record Dates |
Last Update Posted: | February 1, 2008 |
Last Verified: | January 2008 |
Alzheimer's Disease bryostatin 1 bryostatin safety |
efficacy pharmacokinetics pharmacodynamics protein kinase C |
Alzheimer Disease Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases Tauopathies Neurodegenerative Diseases |
Neurocognitive Disorders Mental Disorders Bryostatin 1 Adjuvants, Immunologic Immunologic Factors Physiological Effects of Drugs Antineoplastic Agents |