UnknownPhase 2

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

Lead sponsor

Blanchette Rockefeller Neurosciences Insitute

Asset

Bryostatin 1

Listed sites

Recruiting sites

Enrollment

estimated

Study population

Alzheimer’s disease

Key I/E criteria

•Alzheimer's disease•MMSE 12-26

Primary endpoints

•Adverse Events•Alzheimer's Disease Assessment Scale•Clinician's Interview Based Impression of Change

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study IDBRY-201

NCT IDNCT00606164

Timeline

Milestones

Study first posted2008-02-01estimated

Last update posted2008-02-01estimated

Study start2008-04 (month precision)

Primary completion2008-12estimated (month precision)

Study completion2008-12estimated (month precision)

Assets

Drug assets

Bryostatin 1

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age50 Years

SexAll

Healthy volunteersNot accepted

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

Endpoints (20)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Other (unclassified)

Safety / tolerability / PK

Global cognition

Function / daily living

Other clinical outcomes

Global cognition

2 endpoints

Secondary/protocol endpoint

Clinical Dementia Rating Battery

Time frame:24, 48, and 72 hrs post dose and 4-weeks post dose

descriptive

Secondary/protocol endpoint

Severe Impairment Battery

Time frame:24, 48, and 72 hrs post dose and 4-weeks post dose

descriptive

Function / daily living

1 endpoint

Secondary/protocol endpoint

Alzheimer's Disease Cooperative Study - Activities of Daily Living

Time frame:24, 48, and 72 hrs post dose and 4-weeks post dose

descriptive

Safety / tolerability / PK

3 endpoints

Primary/protocol endpoint

Adverse Events

Time frame:4-weeks

event count, event

Secondary/protocol endpoint

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

descriptive

Secondary/protocol endpoint

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

descriptive

Other clinical outcomes

1 endpoint

Secondary/protocol endpoint

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

descriptive

Other (unclassified)

13 endpoints

Primary/protocol endpoint/low confidence

Alzheimer's Disease Assessment Scale

Time frame:4-weeks post dose

descriptive

Primary/protocol endpoint/low confidence

Clinician's Interview Based Impression of Change

Time frame:4-weeks post dose

descriptive