NCT00606164

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
9

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Apr 2008

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 21, 2008

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 1, 2008

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2008

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

February 1, 2008

Status Verified

January 1, 2008

Enrollment Period

8 months

First QC Date

January 21, 2008

Last Update Submit

January 21, 2008

Conditions

Alzheimer's Disease

Keywords

Alzheimer's Diseasebryostatin 1bryostatinsafetyefficacypharmacokineticspharmacodynamicsprotein kinase C

Outcome Measures

Primary Outcomes (3)

  • Adverse Events

    4-weeks

  • Alzheimer's Disease Assessment Scale

    4-weeks post dose

  • Clinician's Interview Based Impression of Change

    4-weeks post dose

Secondary Outcomes (17)

  • 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

    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

  • +12 more secondary outcomes

Study Arms (3)

Placebo

PLACEBO COMPARATOR
Drug: Placebo

10 ug/m2 Bryostatin

EXPERIMENTAL
Drug: Bryostatin for Injection

15 ug/m2 Bryostatin

EXPERIMENTAL
Drug: Bryostatin for Injection

Interventions

Bryostatin for InjectionDRUG

A single one-hour intravenous infusion of 10 or 15 ug/m2 Bryostatin for Injection on Day 1

Also known as: Bryostatin 1, Bryostatin, NSC 339555, CAS No. 83314-01-6
10 ug/m2 Bryostatin15 ug/m2 Bryostatin
PlaceboDRUG

A single one-hour intravenous infusion of placebo on Day 1

Also known as: PET (60/30/10) diluent plus sodium chloride for injection
Placebo

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +10 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chestnut Ridge Center West Virginia University Department of Behavioral Medicine and Psychiatry

Morgantown, West Virginia, 26505, United States

Location

MeSH Terms

Conditions

Alzheimer Disease

Interventions

BryostatinsInjectionsbryostatin 12-phenyl-6-(2'-(4'-(ethoxycarbonyl)thiazolyl))thiazolo(3,2-b)(1,2,4)triazoleSodium Chloride

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Polyether ToxinsPolyether PolyketidesEthers, CyclicEthersOrganic ChemicalsMacrolidesPolyketidesLactonesMacrocyclic CompoundsPolycyclic CompoundsMarine ToxinsToxins, BiologicalBiological FactorsDrug Administration RoutesDrug TherapyTherapeuticsChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • James M Stevenson, MD

    West Virginia University Department of Behavioral Medicine and Psychiatry

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 21, 2008

First Posted

February 1, 2008

Study Start

April 1, 2008

Primary Completion

December 1, 2008

Study Completion

December 1, 2008

Last Updated

February 1, 2008

Record last verified: 2008-01

Locations

US(1)