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AZD0530 in Mild Alzheimer's Disease (Connect Study)

Active, not recruiting

This study will determine the safety and efficacy of the experimental drug AZD0530 (saracatinib) in older adults with mild Alzheimer's disease. Researchers want to know if the drug can slow disease progression by inhibiting the protein Fyn kinase.

Minimum Age Maximum Age Gender Healthy Volunteers
55 Years 85 Years Both No
December 2014
December 2016
152

  • Probable Alzheimer's disease (NIA-Alzheimer's Association core clinical criteria)
  • 18F-Florbetapir scan with evidence of elevated amyloid beta
  • Mini Mental State Examination score of 18-26 (inclusive)
  • Stability of permitted medications for 4 weeks. In particular, allowable are stable doses of antidepressants lacking significant anticholinergic side effects (if participants do not have current depression or a history of major depression within the past year) and cholinesterase inhibitors and memantine if stable for 12 weeks prior to screening
  • Geriatric Depression Scale score of less than 6 (a score ≥6 may be permissible if the subject is judged not to be depressed)
  • Study partner who has frequent contact with participant (average of 10 hours per week or more) and can accompany him or her to most visits and answers questions about the subject
  • Seeing and hearing ability adequate for neuropsychological testing
  • Good general health, with no disease expected to interfere with the study
  • Modified Hackinski score of less than or equal to 4
  • Completion of six grades of education or a good work history
  • Must speak English or Spanish fluently

  • Any significant neurologic disease other than Alzheimer's, such as Parkinson's disease, vascular dementia, Huntington's disease, normal pressure hydrocephalus, brain tumor, progressive supranuclear palsy, seizure disorder, subdural hematoma, or multiple sclerosis
  • History of significant head trauma followed by persistent neurologic defaults or known structural brain abnormalities
  • Screening/baseline MRI scan with evidence of infection, infarction, other focal lesions, multiple lacunes, or lacunes in a critical memory structure
  • Contraindication for MRI studies, including claustrophobia, presence of metal (ferromagnetic) implants, or cardiac pacemaker
  • Major depression, bipolar disorder within the past year or psychotic features, agitation or behavioral problems within the past 3 months, history of schizophrenia
  • History of alcohol or substance abuse or dependence within the past 2 years
  • Clinically significant or unstable medical condition, including uncontrolled hypertension, uncontrolled diabetes, or significant cardiac, pulmonary, renal, hepatic, endocrine, or other systemic disease
  • History within the last 5 years of primary or recurrent cancer, with the exception of non-melanoma skin cancers, resected cutaneous squamous cell carcinoma in situ, basal cell carcinoma, cervical carcinoma in situ, or in situ prostate cancer with normal prostate-specific antigen post-treatment
  • Clinically significant abnormalities in B12 or TFTs that might interfere with the study; a low B12 level is exclusionary, unless follow-up labs indicate insignificance
  • Residence in skilled nursing facility
  • Current or recent participation in any procedures involving radioactive agents, including current, past, or anticipated exposure to radiation in the workplace, such that total radiation dose exposure in a given year would exceed federal limits
  • Neutropenia, defined as absolute neutrophils count of <1,500/microliter
  • Thrombocytopenia, defined as platelet count <100x103/microliter
  • History of interstitial lung disease
  • Pregnant, lactating, or of childbearing potential (women must be 2 years postmenopausal or surgically sterile)
  • For substudy participants, current blood-clotting or bleeding disorder, or significantly abnormal PT or PTT at screening
  • Clinically significant abnormalities in lab-test results

AZD0530 (saracatinib) was originally developed as a cancer therapy but may hold greater promise as an Alzheimer's treatment. In this Phase II clinical trial, participants will be randomly assigned to take either the oral study drug or a placebo for 1 year. The study requires at least four visits during screening and 13 or 14 visits during the treatment period. Participants will undergo neuropsychological tests to measure changes in cognition, FDG-PET scans to measure the drug's effect on glucose activity in the brain, and other procedures.

Past studies have shown that AZD0530 restores memory loss and reverses brain problems in mouse models of Alzheimer’s. This clinical trial will test the potential benefit of AZD0530 to modify Alzheimer's progression in humans. The study drug targets a protein called Fyn kinase, which plays a central role in how clusters of the amyloid beta peptide damage brain cells in people with Alzheimer's disease.

Name City State Zip Status Primary Contact
Barrow Neurological Institute
Phoenix Arizona 85013

Banner Sun Health Research Institute
Sun City Arizona 85351

University of California, Los Angeles
Los Angeles California 90095

Yale Alzheimer's Disease Research Unit
New Haven Connecticut 06510

Georgetown University
Washington, D.C. District of Columbia 20057

Wien Center for Clinical Research/Mount Sinai Medical Center
Miami Beach Florida 33140

University of South Florida - Health Byrd Alzheimer Institute
Tampa Florida 33613

Northwestern University
Chicago Illinois 60611

Rush University Medical Center
Chicago Illinois 60612

Indiana University
Indianapolis Indiana 46202

University of Iowa
Iowa City Iowa 52242

University of Kentucky
Lexington Kentucky 40504

Brigham and Women's Hospital
Boston Massachusetts 02115

University of Michigan, Ann Arbor
Ann Arbor Michigan 48105-2945

Mount Sinai School of Medicine
New York New York 10029

University of Rochester Medical Center
Rochester New York 14620

Wake Forest University Health Sciences
Winston-Salem North Carolina 27157

Oregon Health &amp; Science University
Portland Oregon 97239

University of Pittsburgh, Alzheimer's Disease Research Center
Pittsburgh Pennsylvania 15213

Roper St. Francis Hospital
Charleston South Carolina 29401

University of Washington
Seattle Washington 98108

University of British Columbia, Clinic for AD &amp; Related Disorders
Vancouver British Columbia V6T 1Z3

Yale University

  • University of Southern California, Alzheimer's Therapeutic Research Institute

Name Role Affiliation
Christopher H. van Dyck, MD Study Director Yale University
Paul Aisen, MD Study Director University of Southern California, Alzheimer's Therapeutic Research Institute

Name Phone Email
Shelley Moore 858-616-7557 shelleym@usc.edu
Karen Bowman 858-964-0828 k.bowman@usc.edu

NCT02167256

A Phase IIa Multi-Center Study of 18F-FDG PET, Safety, and Tolerability of AZD0530 in Mild Alzheimer's Disease