Expired Study
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Morgantown, West Virginia 26505


Purpose:

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.


Criteria:

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


NCT ID:

NCT00606164


Primary Contact:

Principal Investigator
James M Stevenson, MD
West Virginia University Department of Behavioral Medicine and Psychiatry


Backup Contact:

N/A


Location Contact:

Morgantown, West Virginia 26505
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: March 16, 2018

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