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

Completed · Phase 2 · Has a placebo group

Conditions studied: Alzheimer's Disease

In brief

AZD0530 is an inhibitor of Src and Abl family kinases1. It has been developed as treatment for malignancies because these kinases play a role in tumor invasion and proliferation. However, the Src family kinases (SFKs) are highly expressed in brain and have major effects on synaptic plasticity2. Moreover, the investigators have recently shown that a specific SFK, namely Fyn, is aberrantly activated by specific conformations of the Amyloid Beta (Aß) peptide from Alzheimer's disease (AD). Genetic deletion of Fyn rescues AD deficits in preclinical models. This clinical trial will test the potential benefit of AZD0530 for Alzheimer's disease modification.

Key facts

Study ID: NCT02167256
Run by: Yale University
People needed: 159
Starts: 2014-12-01
Expected to finish: 2018-02-27
Last updated by the study team: 2019-08-14

Who can join

Age: 55 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

NIA-Alzheimer's Association core clinical criteria for probable AD
18F-Florbetapir scan with evidence of elevated Aβ (based on central review)
Age between 55-85 (inclusive)
MMSE score between 18 and 26 (inclusive)
Stability of permitted medications for 4 weeks. In particular:
Stable doses of antidepressants lacking significant anticholinergic side effects (if they are not currently depressed and do not have a history of major depression within the past 1 year)
Cholinesterase inhibitors and memantine are allowable if stable for 12 weeks prior to screen
Geriatric Depression Scale less than 6 [Note: a score ≥6 on this screening scale may be permissible, if the subject is examined by a site clinician and judged not to be depressed.]
Study partner is available who has frequent contact with the subject (e.g., average of 10 hours per week or more), and can accompany the subject to most visits to answer questions about the subject
Visual and auditory acuity adequate for neuropsychological testing
Good general health with no disease expected to interfere with the study
Subject is not pregnant, lactating, or of childbearing potential (i.e., women must be two years post-menopausal or surgically sterile)
Modified Hachinski less than or equal to 4
Completed six grades of education or has a good work history
Must speak English or Spanish fluently

You may not qualify if…

Any significant neurologic disease other than AD, such as Parkinson's disease, multi-infarct dementia, Huntington's disease, normal pressure hydrocephalus, brain tumor, progressive supranuclear palsy, seizure disorder, subdural hematoma, multiple sclerosis, or history of significant head trauma followed by persistent neurologic defaults or known structural brain abnormalities
Screening/baseline MRI scan with evidence of infection, infarction, or other focal lesions or multiple lacunes or lacunes in a critical memory structure
Subjects that have any contraindications for MRI studies, including claustrophobia, the presence of metal (ferromagnetic) implants, or cardiac pacemaker
Major depression, bipolar disorder as described in DSM-IV within the past 1 year or psychotic features, agitation or behavioral problems within 3 months, which could lead to difficulty complying with the protocol
History of schizophrenia (DSM V criteria)
History of alcohol or substance abuse or dependence within the past 2 years (DSM V criteria)
Clinically significant or unstable medical condition, including uncontrolled hypertension, uncontrolled diabetes, or significant cardiac, pulmonary, renal, hepatic, endocrine, or other systemic disease in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results, or the subject's ability to participate in the study.
Has had a history within the last 5 years of a primary or recurrent malignant disease 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 is exclusionary, unless follow-up labs (homocysteine (HC) and methylmalonic acid (MMA)) indicate that it is not physiologically significant.
Residence in skilled nursing facility.
Use of any excluded medication as described in study protocol
Current or recent participation in any procedures involving radioactive agents, including current, past, or anticipated exposure to radiation in the workplace, such that the total radiation dose exposure to the subject in a given year would exceed the limits of annual and total dose commitment set forth in the US Code of Federal Regulations (CFR) Title 21 Section 361.1. This guideline is an effective dose of 5 rem received per year.
Neutropenia defined as absolute neutrophils count of <1,800/microliter
Thrombocytopenia defined as platelet count <120x103/microliter
For CSF sub-study participants, a current blood clotting or bleeding disorder, or significantly abnormal PT or PTT at screening
Clinically significant abnormalities in screening laboratories, including:
Aspartate aminotransferase (AST) >1.5 times ULN
Alanine aminotransferase (ALT) > 1.5 times ULN
Total bilirubin >1.5 times ULN
Serum creatinine >2.0 times ULN
History of interstitial lung disease
Patients whom the PI deems to be otherwise ineligible

Where it is running

Barrow Neurological Institute — Phoenix, Arizona, United States
Banner Sun Health Research Institute — Sun City, Arizona, United States
University of California, Los Angeles — Los Angeles, California, United States
Yale Alzheimer's Disease Research Unit — New Haven, Connecticut, United States
Georgetown University — Washington D.C., District of Columbia, United States
Wien Center for Clinical Research/Mount Sinai Medical Center — Miami Beach, Florida, United States
University of South Florida - Health Byrd Alzheimer Institute — Tampa, Florida, United States
Northwestern University — Chicago, Illinois, United States
Rush University Medical Center — Chicago, Illinois, United States
Indiana University — Indianapolis, Indiana, United States
University of Iowa — Iowa City, Iowa, United States
University of Kentucky — Lexington, Kentucky, United States
Brigham and Women's Hospital — Boston, Massachusetts, United States
University of Michigan, Ann Arbor — Ann Arbor, Michigan, United States
Mount Sinai School of Medicine — New York, New York, United States
University of Rochester Medical Center — Rochester, New York, United States
Wake Forest University Health Sciences — Winston-Salem, North Carolina, United States
Oregon Health & Science University — Portland, Oregon, United States
University of Pittsburgh, Alzheimer's Disease Research Center — Pittsburgh, Pennsylvania, United States
Roper St. Francis Hospital — Charleston, South Carolina, United States
University of Washington — Seattle, Washington, United States
University of British Columbia, Clinic for AD & Related Disorders — Vancouver, British Columbia, Canada

Full record on ClinicalTrials.gov

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