The ASPECT Study is looking for participants to evaluate the safety and effectiveness of an investigational drug for agitation associated with Alzheimer’s dementia. In order to be eligible for this study, a potential participant must:
There are additional criteria that are included in the questionnaire on this website and some that are reviewed by the study team at the study site at the first appointment.
The ASPECT Study involves attending study appointments, completing study procedures, taking the study drug (investigational drug or placebo), and reporting on the participant’s behaviors.
This initial appointment is an opportunity for you to:
If qualified, participation can last up to 20 weeks with up to 10 appointments with the study site. The study coordinator can answer any questions you have about the ASPECT Study.
The investigational drug being studied in the ASPECT Study is a capsule taken orally.
A placebo is a substance with no active drug. In this case, the placebo looks like the investigational drug but does not contain the active ingredient.
Do not discontinue any medication unless you are advised to do so by the study site staff or your primary care physician.
The health and safety of study participants are always top priority of clinical research study centers. The precautions taken may vary by study center.
The study sites are located throughout the United States and Canada.
There is no cost to you for participating in this study. If you qualify for this study, study-related care will be provided at no cost to you and participants may be compensated for their time.
A research study (also known as a clinical trial) is a medical study that is designed to answer questions about the safety and efficacy of potential new drugs and to find out how well they work. These studies must be performed before a potential new medication or treatment can be approved for use in patients and sold to the general public.
It is important to test drugs and medical products in the people they are meant to help. It is also important to conduct research in a variety of people because each individual may respond differently to treatments.
For each research study, researchers develop eligibility criteria, such as age, gender, previous treatment history, and other medical conditions. Not everyone who applies for a research study will be accepted. Participants will be selected based on the eligibility criteria and the number of participants needed by the researchers.
Research studies are used to test medications before they are sold to the general public. The testing that takes place during the studies provides information regarding the safety and effectiveness of the potential medication.
One way to find information about clinical trials is by searching this website: www.clinicaltrials.gov. ClinicalTrials.gov is an interactive online database, managed by the National Library of Medicine. It provides information about both federally and privately supported clinical research. ClinicalTrials.gov is updated regularly and offers information on each trial’s purpose, who is qualified to participate, locations, and phone numbers to call for more information.
For those who are qualified, taking part in research studies offers benefits:
It is important to test drugs and medical products in the people they are meant to help. It is also important to conduct research in a variety of people because each individual may respond differently to treatments.
For each research study, researchers develop eligibility criteria, such as age, gender, previous treatment history, and other medical conditions. Not everyone who applies for a research study will be accepted. Volunteers may be excluded based on the eligibility criteria and/or the number of participants needed by the researchers.
Research studies can be sponsored by an organization such as a pharmaceutical company, a federal agency such as the Veterans Administration, or an individual, such as a physician or health care provider. The sponsor determines the location(s) of the trials, which are usually conducted at universities, medical centers, clinics, doctor’s offices, and/or at hospitals.
The government requires researchers to give prospective participants complete and accurate information about what will happen during the study. Participants must sign an “informed consent” form before joining the study, indicating they understand that the study is research, and that they can leave the research study at any time. This informed consent helps ensure that a prospective research study participant understands what is involved.
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