Tau Screening Study in Patients With Early Symptomatic AD



Status:Completed
Conditions:Alzheimer Disease
Therapuetic Areas:Neurology
Healthy:No
Age Range:60 - 85
Updated:10/26/2018
Start Date:October 26, 2017
End Date:August 31, 2018

Use our guide to learn which trials are right for you!

A Multicenter Screening Study With Flortaucipir F 18 in Patients With Early Symptomatic AD

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.


Inclusion Criteria:

- Men or women between the ages of 60 and 85 years of age at the time of consent

- Patients with gradual and progressive change in memory function for a period equal to
or greater than six months

- Patients who have a Mini Mental State Examination (MMSE) score in the 20-27 range

- Patients who are willing to undergo a PET scan using flortaucipir F 18

- Patients who give informed consent or have a legally authorized representative (LAR)
to consent for enrollment

Exclusion Criteria:

- Patients who lack adequate premorbid literacy, vision, or hearing to complete the
required psychometric testing in the investigator's opinion

- Females of childbearing potential who are not surgically sterile, not refraining from
sexual activity, or not using reliable contraception methods. Females of childbearing
potential must not be pregnant (negative serum β-Human Chorionic Gonadotropin [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 flortaucipir F 18 injection administration.

- Have significant neurological disease affecting the Central Nervous System (CNS)
(other than AD) that may affect cognition or ability to complete the study, including
but not limited to, other types of dementia, serious brain infections, Parkinson's
disease, multiple concussions, or epilepsy or recurrent seizures (except febrile
childhood seizures).

- Patients with any current primary psychiatric diagnosis other than AD if, in the
opinion of the investigator, the disorder/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).

- 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 du Pointes.

- Have an average electrocardiography (ECG) corrected QT (QTcF) interval measurement >
450 msec (men) or > 470 msec (women) at screening (as determined at the
investigational site).

- Have ocular pathology that significantly limits ability to reliably evaluate vision or
the retina.

- Have a history of alcohol or drug disorder (except tabacco use disorder) within 2
years before the screening visit

- Have a current serious or unstable illness including retinal, 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 less than 24 months.

- Has a history of cancer within the last five years, with the exception of
non-metastatic 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

- Patients with a past history (suspected or confirmed) of Hepatitis B or Hepatitis C

- History of vitiligo and/or current evidence of post-inflammatory hypopigmentation

- Have had prior treatment with a passive anti-amyloid immunotherapy less than five
half-lives prior to randomization.

- Have previously participated in any other study investigating active immunization
against amyloid beta (Aβ)

- 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

- Contraindication to PET

- Has hypersensitivity to flortaucipir F 18 or any of its excipients

- 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

- Has previous magnetic resonance imaging (MRI) evidence of significant abnormality that
would suggest another potential etiology for progressive dementia or a clinically
significant finding that may impact patient's potential to safely participate in study

- Have contraindications for MRI, including claustrophobia or the presence of
contraindicated metal (ferromagnetic) implants/cardiac pacemaker

- Have poor venous access

- Are investigator site personnel directly affiliated with this study and/or immediate
families; immediate family is defined as a spouse, parent, child, or sibling
(biological or legally adopted)

- Are Lilly employees or are employees of third-party organizations (TPOs) involved in a
study that requires exclusion of their employees

- Are otherwise unsuitable for a study of this type in the opinion of the investigator

- Have received treatment with a stable dose of an acetylcholinesterase inhibitor
(AChEI) and/or memantine for less than two months before randomization (if a patient
has recently stopped an AChEI and/or memantine, he/she must have discontinued
treatment at least two months before randomization).

- Current use of strong inducers of CYP3A

- Are currently on medication(s) known to significantly prolong the QT interval

- Have allergies to either monoclonal antibodies, diphenhydramine, epinephrine, or
methylprednisolone

- Have known allergies to LY3002813, related compounds, or any components of the
formulation; or history of significant atopy

- Have known allergies to LY3202626, related compounds, or any components of the
formulation

- Changes in concomitant medications that could potentially affect cognition and their
dosing should be stable for at least one month before screening, and between screening
and randomization (does not apply to medications discontinued due to exclusions or
with limited duration of use, such as antibiotics)
We found this trial at
10
sites
Bennington, Vermont 05201
Principal Investigator: Diana Michalczuk, PsyD
Phone: 413-281-0577
?
mi
from
Bennington, VT
Click here to add this to my saved trials
Delray Beach, Florida 33445
Principal Investigator: Mark Brody, MD
Phone: 561-702-0257
?
mi
from
Delray Beach, FL
Click here to add this to my saved trials
Newton, Massachusetts 02459
Principal Investigator: Paul Solomon, PhD
Phone: 627-699-6927
?
mi
from
Newton, MA
Click here to add this to my saved trials
100 West Gore Street
Orlando, Florida 32806
Principal Investigator: Ira Goodman, MD
Phone: 407-426-9299
?
mi
from
Orlando, FL
Click here to add this to my saved trials
San Diego, California 92103
Principal Investigator: Stephen Thein, PhD
Phone: 619-294-4302
?
mi
from
San Diego, CA
Click here to add this to my saved trials
Santa Ana, California 92705
Principal Investigator: John Duffy, MD
Phone: 714-542-3008
?
mi
from
Santa Ana, CA
Click here to add this to my saved trials
Tampa, Florida 33609
Principal Investigator: Susan Steen, MD
Phone: 813-353-9613
?
mi
from
Tampa, FL
Click here to add this to my saved trials
1 Valleybrook Drive
Toronto, Ontario M3B 2S7
Principal Investigator: Sharon Cohen, MD
Phone: 416-386-9761
?
mi
from
Toronto,
Click here to add this to my saved trials
Willow Grove, Pennsylvania 19090
Principal Investigator: David Weisman, MD
Phone: 215-957-9250
?
mi
from
Willow Grove, PA
Click here to add this to my saved trials
Winston-Salem, North Carolina 27103
Principal Investigator: Giles Crowell, Md
Phone: 336-768-8062
?
mi
from
Winston-Salem, NC
Click here to add this to my saved trials