Additional Information -

               The screening for this study includes having an eye exam offsite.  This appointment may be done the same day as your screening or on a different day depending on the appointments the eye doctor has available. 

                There will be a spinal tap done during this study.

                NOTE: Some medications are allowed per PI approval.

                                 ______________________________________________

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Healthy SA 4597-0002 MAD

San Antonio - Texas

ICON Early Phase Services is conducting a research study for healthy adults age 60 and over. This study is being done to test a potential treatment for Alzheimer’s disease.

Vital signs, ECGs, physical examinations, eye exams, pregnancy, drug and alcohol screens and cerebrospinal fluid sampling will be performed. Blood and urine samples will also be obtained during this study. 

Participants will complete:

  •  1 screening visit
  •  10 consecutive overnights
  •  1 outpatient visit

To determine if you fully qualify, it will be necessary to obtain blood samples after an 8- hour fast.  You have the option of fasting for the screening appointment, or, you may return at a later date. If ICON does not have your medical records on file, you will need to provide medical records at screening.  For more information, see below.

Qualified participants may be compensated up to $5,600 for time and travel.

 

If you are able to answer “YES” to the following statements, you may qualify for this study.

 

  • I am a healthy adult, meaning no significant medical conditions

 

  • I am 60 years old or older

 

  • My BMI is between 18.0 and 32.0 kg/m2 (inclusive) and I weigh at least 110 lbs.

 

  • I am a nonsmoker and I have not used any tobacco or nicotine-containing products recently (e.g., cigarettes, chewing tobacco, snuff, nicotine patches or electronic cigarettes).  I agree not to use any of these products while on study and to abide by the rules of the clinic, which is a non-smoking facility.

 

  • I have not received any investigational drug or participated in any clinical study within 5 half-lives or 30 days prior to first dose

 

  • If Female, I am not pregnant or breastfeeding   

 

  • If Female and not capable of becoming pregnant, I have been postmenopausal for at least 1 year or I am surgically sterile (hysterectomy, ovaries removed or tubes tied)   

 

  • If Male and I have a partner capable of becoming pregnant, I agree to use a condom from screening through 5 half-lives or 90 days after the last dose

 

  • If Male and I have a partner capable of becoming pregnant, my partner must be willing to use a form of contraception (a barrier method, intrauterine device, or hormonal contraception) from screening through 5 half-lives or 90 days after the last dose 

 

  • If Male, I must agree not to donate sperm from screening through 5 half-lives or 90 days after the last dose

 

  • I am able to communicate effectively in English with the study personnel

 

  • I have not had gastric bypass surgery or a gastrectomy

 

  • I have not had prior back surgery or a herniated disc

 

  • I have not recently had surgery or major trauma or any planned surgery while on study

 

  • I do not have a recent history of alcohol abuse, or drug abuse or addiction

 

  • I do not have an active eye disease

 

  • I have not used any prescription medications recently

 

  • I have not used any over the counter drugs (including herbal) recently

 

  • I have not had a vaccination recently

 

  • I have not recently experienced significant blood loss or donated blood/plasma

 

  • I am willing and able to consume standardized meals while on study

 

  • I am able to comply with the restrictions on strenuous activity, the consumption of alcohol and certain fruits and juices, participation in other studies and the donation of blood/plasma as required by the study.

 

It is important to understand that even if you feel that you meet all the above criteria, you are still required to complete the protocol screening procedures.  Scheduling a screening appointment does not guarantee that you will qualify for that study. Additionally, subjects are screened on a first come-first served basis and studies may complete enrollment prior to your visit.  Additionally, no guarantees can be made regarding group assignments for any particular study.  ICON will not assume any liability for lost time, travel or failure to qualify.

To determine if you fully qualify, it will be necessary to obtain blood and urine  samples after an 8-hour fast.  You have the option of fasting for a blood or urine sample at the screening appointment, or, you may return at a later date for us to obtain these samples. 

If you fast, you should refrain from eating or drinking anything (with the exception of water) for 8 hours before your appointment.  We will be testing for tobacco and alcohol use and drug abuse.  Please refrain from consuming alcohol at least 24 hours prior to your screening appointment. 

Be sure to bring all of your medications with you to your screening appointment. 

Please note, you need to bring a valid, non-expired photo ID with you when you attend your screening visit.  We accept a government issued identification card such as a driver's license, state issued ID card, passport or military ID.  You will be required to show this same photo ID at all study visits.

You will be filling out paperwork for the study.  Please arrive at least 30 minutes in advance of your screening appointment.  If you are late for your appointment you may not be seen or may need to reschedule. 

Be advised that you may need to provide medical records as part of the screening process for this study.  If possible, please bring your full medical records with you to your screening appointment.  If you cannot bring your records with you, you must provide them before you can admit to the study.  Note that full medical records include surgical reports.  You will not be allowed to participate in the study without medical records defined as:

  • All medical records, including but not limited to: office notes, face sheets, history and physical, consultation notes, inpatient, outpatient and emergency room treatment, all clinical charts, reports, surgical reports, order sheets, progress notes, nurse's notes, social worker records, clinic records, treatment plans, admission records, discharge summaries, reports of consultations, documents, correspondence, test results, statements, questionnaires/histories, from your medical provider(s).
  • For females, surgical reports are required as documentation for procedures such as hysterectomy, bilateral oophorectomy and tubal ligation. 

 

If you are able to answer “YES” to the above questions and would like to make an appointment online please click on the following link:

                    CLICK HERE To Make An Appointment For SA 4597-0002 MAD

                                       ______________________________

              STUDY DATES - Note: All dates and times are tentative and may change.

 

                         Cohort 2A  

                              Admit: Dec 10, 2019 Tue  -  Discharge: Dec 20, 2019 Fri

                                 End of Study Visit: Dec 31, 2019 Tue

 

 

Notice:

In order to schedule a screening appointment online, you will be required to enter your personal information (name, date of birth, etc.) into a secure, password protected database.  Your information will remain confidential and will not be accessible by any party that does not work directly for ICON Early Phase Services.  It may be necessary for the recruitment staff to contact you by phone in the event of a schedule change or if more information is needed.  You have the right to remove your information from the database at any time by logging in to the scheduling program and choosing “My Profile” and then selecting the “Terminate Account” button.   

 

PURSUANT TO SECTION 30.06,
PENAL CODE (TRESPASS BY HOLDER OF A LICENSE TO CARRY A CONCEALED HANDGUN)
A PERSON LICENSED UNDER SUBCHAPTER H, CHAPTER 411, GOVERNMENT CODE (CONCEALED HANDGUN LAW), MAY NOT ENTER THIS PROPERTY WITH A CONCEALED HANDGUN.

 

Reference SA 4597-0002 MAD
Name
Details Healthy SA 4597-0002 MAD - Adults age 60 and older
Gender Male or Female
Dates -
Payment amount up to $5,600
Age 60 and older -

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