.

 

UPDATE:  Please note that the design of this study will be changing.  It will no longer be for age 60 and older but change to age 18-49.  We have no information at this time of when this study will restart. 

 

               _____________________________________________

 

 Additional information - 

               No out-of-state patients are being accepted for this study.

               If you dosed for one of the other parts of SA 4597-0002, you cannot do this study.

                           _____________________________________

HEALTHY SA 4597-0002

San Antonio- TX

ICON Early Phase Services is conducting a research study for healthy adults age 60 and older.  This study is being done to test a potential treatment for Alzheimer’s disease.  Dosing will be done using an oral solution.

Vital signs, ECGs, physical examinations and pregnancy, drug, alcohol and tobacco screens will be performed. Blood and urine samples will also be obtained during this study. 

Total participation is 9 days (plus screening).  Participants will complete:

  •  1 screening visit
  •  4 overnights (2 periods/2 nights each)
  •  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 $3,000 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 age 60 or older  

 

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

 

  • I have not taken any other investigational drug, or participated in any clinical study, within 30 days (or 5 half-lives) of first dose

 

  • I am not currently participating in another clinical study

 

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

 

  • If Male and I have a partner capable of becoming pregnant, I agree to use a condom from screening through 90 days (or 5 half-lives) after last dose.  My partner must be willing to use a medically acceptable method of contraception (a barrier method, intrauterine device, or hormonal contraception) for the same length of time.   

 

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

 

  • I am a nonsmoker and I have not recently used tobacco or nicotine-containing products (e.g., cigarettes, chewing tobacco, snuff, nicotine patches, and electronic cigarettes)

 

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

 

  • I have not had prior gastrointestinal surgery such as gastric bypass or a gastrectomy

 

  • I do not have a history or presence of serious head injury, unexplained fainting, loss of consciousness, central nervous system disease or dementia

 

  • I do not have a history of suicidal behavior and/or ongoing suicidal ideation

 

  • I have not had surgery or major trauma recently and I do not plan to have surgery during the study

 

  • I do not have a recent history of alcohol abuse, illicit drug use, significant mental illness, physical dependence to any opioid, or any history of drug abuse or addiction

 

  • I have not recently used prescription medications or drugs that are exclusionary for the study

 

  • I have not recently used over-the-counter drugs, including herbal preparations (NOTE: a certain dosage of acetaminophen will be allowed)

 

  • I have not recently received a vaccination    

 

  • I have not recently experienced significant blood loss, or donated blood or blood products

 

  • I am able to consume standardized meals while on study

 

  • I am able to avoid strenuous activity prior to admission and while in-house for the study as required

 

  • I am able to follow dietary restrictions as required by the study (e.g., drug inhibitors and inducers, CYPs, grapefruit, cranberry, pomegranate)

 

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.  

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 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, military ID or passport.  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

 

                          ___________________________________

 

  Study Dates - Note: All dates and times are tenative and may change.

     Cohort 1

         1st Admit: Mar 30, 2020 Mon- Discharge: Apr 01, 2020 Wed

         2nd Admit: Apr 06, 2020 Mon - Discharge: Apr 08, 2020 Wed

 

 

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
Name
Details Healthy SA 4597-0002 - Texas residents only. No out-of-state patients. STUDY ON HOLD
Gender Male or Female
Dates -
Payment amount up to $3,000
Age -

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