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Alzheimer's DiseasePhase 2NCT02167256

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

A Phase 2 study testing AZD0530 100mg daily and AZD0530 125mg daily in people with Alzheimer's Disease, run by Yale University at 22 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 55 to 85 years
Conditions the study is for
Alzheimer's Disease
What is being tested?
AZD0530 100mg daily and AZD0530 125mg daily
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
159 participants
Where
22 sitesin 2 countries
Study dates
Dec 2014to 27 Feb 2018
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 55 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
Show all 15Show fewer
  • 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

Who cannot join

  • 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)
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  • 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

Trial locations and contacts

22 sites in 2 countries.

22 sites in 2 countries

United States21 sites

  • University of Michigan, Ann Arbor

    Ann Arbor, Michigan, 48105-2945

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

  • Roper St. Francis Hospital

    Charleston, South Carolina, 29401

  • 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

  • University of California, Los Angeles

    Los Angeles, California, 90095

  • Wien Center for Clinical Research/Mount Sinai Medical Center

    Miami Beach, Florida, 33140

  • Yale Alzheimer's Disease Research Unit

    New Haven, Connecticut, 06510

  • Mount Sinai School of Medicine

    New York, New York, 10029

  • Barrow Neurological Institute

    Phoenix, Arizona, 85013

  • University of Pittsburgh, Alzheimer's Disease Research Center

    Pittsburgh, Pennsylvania, 15213

  • Oregon Health & Science University

    Portland, Oregon, 97239

  • University of Rochester Medical Center

    Rochester, New York, 14620

  • University of Washington

    Seattle, Washington, 98108

  • Banner Sun Health Research Institute

    Sun City, Arizona, 85351

  • University of South Florida - Health Byrd Alzheimer Institute

    Tampa, Florida, 33613

  • Georgetown University

    Washington D.C., District of Columbia, 20057

  • Wake Forest University Health Sciences

    Winston-Salem, North Carolina, 27157

Other trials in United States

Canada1 site

  • University of British Columbia, Clinic for AD & Related Disorders

    Vancouver, British Columbia, V6T 1Z3

Other trials in Canada

About this study

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.

Being tested
AZD0530 100mg daily, AZD0530 125mg daily, Placebo
Medical subject headings
Alzheimer Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AZD0530 100mg dailyDrug

    Also called saracatinib

    All patients in experimental group (50%) will be started on 100mg AZD0530 daily

  • AZD0530 125mg dailyDrug

    Also called saracatinib

    Patients with plasma drug level <100ng/ml after 2 weeks of 100mg AZD0530 daily will receive 125mg daily of AZD0530.

  • PlaceboDrug

    Also called saracatinib

    50% of patients will receive placebo treatment for the duration of the study.

Study groups in NCT02167256
Study groupRoleWhat they receive
AZD0530 100mg dailyExperimentalPatients in the experimental group (50%) will be started on this dose. After 2 weeks, patients with a plasma drug level of <100ng/ml will receive 125mg AZD0530 daily and remain in the same experimental group as patient receiving 100mg daily.
Receives: Drug: AZD0530 100mg daily; Drug: AZD0530 125mg daily
AZD0530 PlaceboPlacebo comparator50% of patients will receive placebo treatment for the duration of the study,
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Brain Glucose Uptake Measured Using 18F-FDG PET Imaging

    Composite measure of brain glucose uptake using F18-FDG PET in a pre-defined set of brain regions, between baseline and 12 months.

    Measured: 12 months

  2. Number of Participants With One or More Serious/Other Adverse Events Subjects With Mild AD as Assessed by Analysis of Adverse Events, Including Symptoms, and Abnormal Findings on Physical and Neurological Examinations, and Standard Labs.

    Assessment of any adverse effects between drug and placebo-treated subjects

    Measured: 12 months

Secondary outcomes (4)

  1. The Effect of Treatment With AZD0530 on Cognitive and Behavioral Function

    The change in cognitive function between baseline and 12 months will be measured by the following tests:

    1. Alzheimer Disease Assessment Scale - Cognitive 11 (ADAS-cog11). Measures: Cognitive function Maximum score: 70; Minimum score: 0. Higher score equals worse cognitive function
    2. Mini-Mental State Examination (MMSE) Measures: Cognitive Function Maximum score: 30; Minimum score: 0. Higher score equal better cognitive function
    3. Alzheimer Disease Cooperative Study - Activities of Daily Living Inventory (ADCS-ADL) Measures: Ability to perform routine daily activities Maximum score: 78; Minimum score: 0. Higher score equals better ability to perform activities of daily living
    4. Clinical Dementia Rating Sum of Boxes (CDR-SO) Measures: Dementia severity Maximum score: 18; Minimum score: 0. Higher score equals more severe dementia.

    Measured: 12 months

  2. Percent Change in Brain Volume Before and After Treatment

    Change in volume of pre-defined brain regions between baseline and 12 months of treatment.

    Measured: 12 months

  3. Cerebrospinal Fluid Levels of Total Tau, Phospho-tau (p-Tau), and Amyloid-beta 1-42 (Abeta 1-42)

    Measure concentration of Tau and Amyloid-beta 1-42 biomarkers in the cerebrospinal fluid between baseline and 12 months of treatment

    Measured: 12 months

  4. Change in Brain Glucose Uptake Measured Using 18F-FDG PET Imaging

    The results from the primary outcome with brain FDG-PET imaging was analyzed by ApoE genotype. Composite measure of brain glucose uptake using F18-FDG PET in a pre-defined set of brain regions, between baseline and 12 months.

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jun 2014 (estimated)
  2. Study startDec 2014
  3. Primary completion27 Feb 2018
  4. Study completion27 Feb 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
159 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02167256
Sponsor's protocol ID
1404013830
Other IDs
4UH3TR000967-02
Status last verified
Jul 2019
First submitted
12 Jun 2014
Last updated
14 Aug 2019
Data monitoring committee
Yes

Publications

  • Jimenez-Maggiora GA, Donohue MC, Rafii MS, Raman R, Aisen PS. Artificial intelligence-enabled safety monitoring in Alzheimer's disease clinical trials. J Prev Alzheimers Dis. 2025 Jan;12(1):100002. doi: 10.1016/j.tjpad.2024.100002. Epub 2025 Jan 1.

    PubMed 39800465

  • Donohue MC, Langford O, Insel PS, van Dyck CH, Petersen RC, Craft S, Sethuraman G, Raman R, Aisen PS; Alzheimer's Disease Neuroimaging Initiative. Natural cubic splines for the analysis of Alzheimer's clinical trials. Pharm Stat. 2023 May-Jun;22(3):508-519. doi: 10.1002/pst.2285. Epub 2023 Jan 10.

    PubMed 36627206

  • van Dyck CH, Nygaard HB, Chen K, Donohue MC, Raman R, Rissman RA, Brewer JB, Koeppe RA, Chow TW, Rafii MS, Gessert D, Choi J, Turner RS, Kaye JA, Gale SA, Reiman EM, Aisen PS, Strittmatter SM. Effect of AZD0530 on Cerebral Metabolic Decline in Alzheimer Disease: A Randomized Clinical Trial. JAMA Neurol. 2019 Oct 1;76(10):1219-1229. doi: 10.1001/jamaneurol.2019.2050.

    PubMed 31329216

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing AZD0530 100mg daily and AZD0530 125mg daily in people with Alzheimer's Disease, run by Yale University at 22 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 22 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Aug 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Brain Glucose Uptake Measured Using 18F-FDG PET Imaging (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02167256, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2019.

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