Tau Screening Study in Subjects With Early Symptomatic AD
Status: | Completed |
---|---|
Conditions: | Alzheimer Disease |
Therapuetic Areas: | Neurology |
Healthy: | No |
Age Range: | 60 - 85 |
Updated: | 12/8/2018 |
Start Date: | March 8, 2018 |
End Date: | November 15, 2018 |
A Multicenter Screening Study With Flortaucipir F 18 in Patients With Early Symptomatic AD; #2
This protocol is designed to serve as a pre-screening study for subjects who are potentially
eligible for Alzheimer's Disease (AD) therapeutic trials that require tau imaging for
inclusion by means of a flortaucipir F18 Positron Emission Tomography (PET) scan.
eligible for Alzheimer's Disease (AD) therapeutic trials that require tau imaging for
inclusion by means of a flortaucipir F18 Positron Emission Tomography (PET) scan.
Inclusion Criteria:
1. Patients with gradual and progressive change in memory function reported by the
patient or informant for ≥6 months
2. Patients who have a MMSE score between 20-28 inclusive
3. Patients who are willing to undergo a PET scan using flortaucipir F 18
4. Patients who give informed consent or have a legally authorized representative (LAR)
available to consent at the time of enrollment
5. A study partner who must be available if the patient enters the treatment trial
Exclusion Criteria:
1. Are females of childbearing potential who are not surgically sterile, not refraining
from sexual activity or not using reliable methods of contraception. Females of
childbearing potential must not be pregnant (negative serum β-HCG at screening and
negative urine β-HCG prior to flortaucipir F 18 injection) or breastfeeding at
screening. Females should agree to avoid becoming pregnant by refraining from sexual
activity or using reliable contraceptive methods for 24 hours following administration
of flortaucipir F 18 injection;
2. Patients who lack, in the investigator's opinion, adequate premorbid literacy,
adequate vision, or adequate hearing to complete the required psychometric testing;
3. Have significant neurological disease affecting the CNS, other than AD, that may
affect cognition or ability to complete the study, including but not limited to, other
dementias, serious infection of the brain, Parkinson's disease, multiple concussions,
or epilepsy or recurrent seizures (except febrile childhood seizures);
4. Patients with any current primary psychiatric diagnosis other than AD if, in the
judgment of the investigator, the psychiatric disorder or symptom is likely to
confound interpretation of drug effect, affect cognitive assessment, or affect the
patient's ability to complete the study [Patients with history of schizophrenia or
other chronic psychosis are excluded.];
5. Have a current serious or unstable illness including, cardiovascular, hepatic, renal,
gastroenterologic, respiratory, endocrinologic, neurologic (other than AD),
psychiatric, immunologic, or hematologic disease and other conditions that, in the
investigator's opinion, could interfere with the analyses in this study; or has a life
expectancy of <24 months;
6. Has a history of cancer within the last 5 years, with the exception of nonmetastatic
basal and/or squamous cell carcinoma of the skin, in situ cervical cancer,
non-progressive prostate cancer, or other cancers with low risk of recurrence or
spread;
7. Have a past history (suspected or confirmed) of Hepatitis B or Hepatitis C;
8. Are clinically judged by the investigator to be at serious risk for suicide as
assessed by medical history, examination, or the C-SSRS.
9. Have a history of alcohol or drug disorder (except tobacco use disorder) within 2
years before the screening visit;
10. Have a history of clinically significant multiple or severe drug allergies or severe
post treatment hypersensitivity reactions (including but not limited to erythema
multiforme major, linear immunoglobulin A dermatosis, toxic epidermal necrolysis,
and/or exfoliative dermatitis)
11. Have known positive serologic findings for human immunodeficiency virus (HIV)
antibodies. Local laws and regulations may apply to whether testing is required.
12. Has previous MRI evidence of significant abnormality that would suggest another
potential etiology for progressive dementia or a clinically significant finding that
may impact the patient's ability to safely participate in the study;
13. Have any contraindications for MRI, including claustrophobia or the presence of
contraindicated metal (ferromagnetic) implants/cardiac pacemaker;
14. Have any clinically important abnormality at screening, as determined by investigator,
in physical or neurological examination, vital signs, ECG, or clinical laboratory test
results that could be detrimental to the patient, could compromise the study, or show
evidence of other etiologies for dementia.
15. Has hypersensitivity to flortaucipir F 18 or any of its excipients;
16. Intend to use drugs known to significantly prolong the QT interval within 14 days or 5
half-lives, whichever is longer, of a scheduled screening/baseline flortaucipir F 18
PET scan, or have medical history of risk factors for torsades de pointes.
17. Have an ECG corrected QT (QTcF) interval measurement >450 msec (men) or >470 msec
(women) at screening (as determined at the investigational site).
18. Have poor venous access;
19. Contraindication to PET;
20. Present or planned exposure to ionizing radiation that, in combination with the
planned administration of study PET ligands, would result in a cumulative exposure
that exceeds local recommended exposure limits;
21. Patients that are currently enrolled in any other interventional clinical trial
involving an investigational product or any other type of medical research judged not
to be scientifically or medically compatible with this study
22. Have participated, within the last 30 days in a clinical trial involving an
investigational product. If the previous investigational product is scientifically or
medically incompatible with this study and has a long half-life, 3 months or 5
half-lives (whichever is longer) should have passed prior to screening (Participation
in observational studies may be permitted upon review of the observational study
protocol and approval by the sponsor).
23. Are investigator site personnel directly affiliated with this study and/or their
immediate families; immediate family is defined as spouse, parent, child, or sibling
whether biological or legally adopted;
24. Are Lilly employees or are employees of third-party organizations (TPOs) involved in a
study that requires exclusion of their employees;
25. In the opinion of the investigator, are otherwise unsuitable for a study of this type.
26. Have received treatment with a stable dose of an acetylcholinesterase inhibitor
(AChEI) and/or memantine for less than 1 months [If a patient has recently stopped an
AChEI and/or memantine, he or she must have discontinued treatment at least 1 months
prior].
27. Have changes in concomitant medications that could potentially affect cognition and
their dosing should be stable for at least 1 month before screening, (does not apply
to medications with limited duration of use, such as antibiotics).
28. Have received active immunization agents for the treatment of Alzheimer's Disease
29. Have known allergies to LY3303560, related compounds, or any components of the
formulation; or history of significant atopy
30. Have allergies to either monoclonal antibodies, diphenhydramine, epinephrine, or
methylprednisolone;
31. Are receiving IgG therapy (also known as gamma globulin or intravenous immunoglobulin
[IVIG])
We found this trial at
9
sites
Chicago, Illinois 60640
Principal Investigator: Jeffrey Ross, MD
Phone: 773-275-3500
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104 SE 1st Avenue
Ocala, Florida 34471
Ocala, Florida 34471
352-629-5800

Principal Investigator: John Paul Nardandrea, MD
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823 SW Mulvane St
Topeka, Kansas 66606
Topeka, Kansas 66606
785-368-0741
Principal Investigator: Michael Cox, MD
Phone: 785-368-0745
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Delray Beach, Florida 33445
Principal Investigator: Mark Broday, MD
Phone: 561-734-8461
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Fort Myers, Florida 33912
Principal Investigator: Wendy Robinson Bond, MD
Phone: 239-939-7777
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Irvine, California 92618
Principal Investigator: Elly Lee, MD
Phone: 949-753-1663
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100 West Gore Street
Orlando, Florida 32806
Orlando, Florida 32806
Principal Investigator: Esteban Olivera, MD
Phone: 407-426-9299
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Port Orange, Florida 32127
Principal Investigator: Alexander White, MD
Phone: 386-304-7070
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345 Blackstone Blvd
Providence, Rhode Island 02906
Providence, Rhode Island 02906
(401) 455-6200

Principal Investigator: Stephen Salloway, MD
Phone: 401-455-6403
Butler Hospital Founded in 1844, Butler Hospital is the state's only non-profit, free-standing psychiatric hospital...
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