ICON Early Phase Services is conducting a research study for healthy adults ages 18-60. This study is being done to test a potential treatment for Alzheimer’s disease.
Vital signs, ECGs, physical examinations and pregnancy, drug and alcohol screens will be performed. Blood and urine samples will also be obtained during this study.
Participants will complete:
- 1 screening visit
- 3 consecutive overnights
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.
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 between 18 and 60 (inclusive) years old
- 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. I agree not to us 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 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
- If Male and I have a partner capable of becoming pregnant, my partner must be willing to use a form of contraception as described above
- If Male, I must agree not to donate sperm from screening until 90 days after the last dose
- I am able to communicate effectively in English with the study personnel
- I have not had prior back surgery
- I have not had surgery or major trauma within 12 weeks of screening
- 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 experienced significant blood loss recently or donated blood/plasma
- I am willing and able to consume standardized meals while on 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 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.