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



Status:Completed
Conditions:Alzheimer Disease
Therapuetic Areas:Neurology
Healthy:No
Age Range:55 - 85
Updated:6/29/2018
Start Date:December 2014
End Date:February 27, 2018

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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.


Inclusion Criteria

1. NIA-Alzheimer's Association core clinical criteria for probable AD

2. 18F-Florbetapir scan with evidence of elevated Aβ (based on central review)

3. Age between 55-85 (inclusive)

4. MMSE score between 18 and 26 (inclusive)

5. 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

6. 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.]

7. 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

8. Visual and auditory acuity adequate for neuropsychological testing

9. Good general health with no disease expected to interfere with the study

10. Subject is not pregnant, lactating, or of childbearing potential (i.e., women must be
two years post-menopausal or surgically sterile)

11. Modified Hackinski less than or equal to 4

12. Completed six grades of education or has a good work history

13. Must speak English or Spanish fluently

Exclusion Criteria

1. 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

2. Screening/baseline MRI scan with evidence of infection, infarction, or other focal
lesions or multiple lacunes or lacunes in a critical memory structure

3. Subjects that have any contraindications for MRI studies, including claustrophobia,
the presence of metal (ferromagnetic) implants, or cardiac pacemaker

4. 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

5. History of schizophrenia (DSM V criteria)

6. History of alcohol or substance abuse or dependence within the past 2 years (DSM V
criteria)

7. 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.

8. 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

9. 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.

10. Residence in skilled nursing facility.

11. Use of any excluded medication as described in study protocol

12. 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.

13. Neutropenia defined as absolute neutrophils count of <1,800/microliter

14. Thrombocytopenia defined as platelet count <120x103/microliter

15. For CSF sub-study participants, a current blood clotting or bleeding disorder, or
significantly abnormal PT or PTT at screening

16. 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

17. History of interstitial lung disease

18. Patients whom the PI deems to be otherwise ineligible
We found this trial at
22
sites
425 University Blvd.
Indianapolis, Indiana 46202
(317) 274-4591
Indiana University INDIANA UNIVERSITY is a major multi-campus public research institution, grounded in the liberal...
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75 Francis street
Boston, Massachusetts 02115
(617) 732-5500
Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
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Boston, MA
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101 Jessup Hall
Iowa City, Iowa 52242
(319) 335-3500
University of Iowa With just over 30,000 students, the University of Iowa is one of...
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Iowa City, IA
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Los Angeles, California 90095
310-825-4321
University of California at Los Angeles The University of California, Los Angeles (UCLA) is an...
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Los Angeles, CA
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
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Portland, OR
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601 Elmwood Avenue
Rochester, New York 14642
(585) 275-2100
Univ of Rochester Medical Center One of the nation's top academic medical centers, the University...
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Rochester, NY
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Seattle, Washington 98104
(206) 543-2100
Univ of Washington Founded in 1861 by a private gift of 10 acres in what...
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Seattle, WA
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Ann Arbor, Michigan 48105
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Ann Arbor, MI
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Charleston, South Carolina 29401
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Charleston, SC
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303 East Superior Street
Chicago, Illinois 60611
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Chicago, IL
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1653 W. Congress Parkway
Chicago, Illinois 60612
(312) 942-5000
Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
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Chicago, IL
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Lexington, Kentucky
859) 257-9000
University of Kentucky The University of Kentucky is a public, land grant university dedicated to...
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Lexington, KY
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Miami Beach, FL
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New Haven, Connecticut 06510
Principal Investigator: Christopher H van Dyck, MD
Phone: 203-764-8100
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New Haven, CT
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New York, New York 10029
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New York, NY
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Phoenix, Arizona 85013
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Pittsburgh, PA
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Sun City, Arizona 85351
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Tampa, FL
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Vancouver,
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3700 O St NW
Washington, District of Columbia 20057
(202) 687-0100
Georgetown University Georgetown University is one of the world's leading academic and research institutions, offering...
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1 Medical Center Blvd
Winston-Salem, North Carolina 27157
336-716-2011
Wake Forest University Health Sciences Welcome to Wake Forest Baptist Medical Center, a fully integrated...
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Winston-Salem, NC
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