UC Davis Health Clinical Studies

A Study of the Experimental Medicine ANAVEX2-73 For Rett Syndrome

Volunteer for research at UC Davis and contribute to discoveries that may improve health care for you, your family, and your community!

This research is being done to answer important questions that might help change or improve treatment for Rett Syndrome. Rett syndrome (RTT) is a rare genetic progressive neurodevelopmental disorder. It is mostly linked to mutations in the MECP2 gene. This affects multiple brain functions including communication, gait, and hand use. Because the MECP2 is gene is on the chromosome, few males live past birth. Therefore, most affected individuals with RTT are females. RTT becomes evident between 1.5-3 years of life. Signs are early developmental regression, expressive language and fine motor (hand) function difficulties . Other clinical manifestations are: - repetitive hand movements - impairment in ambulation - severe intellectual disability - breathing abnormalities while awake - seizures - sleep problems - behavioral problems such as anxiety, disruptive behavior, and mood abnormalities. The experimental drug being tested in this study is called ANAVEX®2-73. Since it is still being studied (experimental), it is not yet approved by the U.S. Food and Drug Administration (FDA), and doctors cannot prescribe it. We want to get more information about how ANAVEX®2-73 might: - improve cognition and sleep, - decrease anxiety and other behaviors, - improve motor function and seizures, if applicable in people with RTT.

Drug study, Phase 2
Female, age 18 to 45 years old

Online Developmental Screening Study

Have you had a new baby? Learn about your baby's development!

Researchers at the UC Davis MIND Institute on the UC Davis Medical Center campus in Sacramento are conducting an online study tracking the development of infants from 6 to 36 months of age. The goal of the study is to help parents understand their child’s development and gain access to resources when needed. This study tests new online methods of tracking developmental milestones in babies. The UC Davis MIND Institute is a collaborative international research center, committed to the awareness, understanding, prevention and care of neurodevelopmental disorders.

Longitudinal screening study
Any, age 6 months

A Study of the Long-Term Safety and Tolerability of Experimental ZYN002 in Children and Adolescents With Fragile X Syndrome (FXS)

Volunteer for research at UC Davis and contribute to discoveries that may improve health care for you, your family, and your community!

Fragile X Syndrome (FXS) is a genetic condition caused by a mutation in the Fragile X mental retardation 1 (FMR1) gene. This mutation is thought to cause changes to the “endocannabinoid system.” This is a certain pathway in the central nervous system. Disruption in this pathway can lead to FXS symptoms such as: - mild to severe intellectual or developmental disability - speech and language difficulties - behavioral, social and emotional difficulties. Cannabidiol (CBD) is part of the Cannabis/Marijuana plant. However, it does not have the same effects on the brain that recreational marijuana has. It may affect the endocannabinoid pathway. The Drug Product ZYN002 is a pharmaceutically manufactured CBD. It is being developed as a clear gel that can be applied to the skin (called transdermal delivery). This provides consistent, controlled levels of CBD in the blood when it is given once or twice a day. The purpose of this study is to evaluate the long-term safety, tolerability and effectiveness of the experimental drug ZYN002. It will be used in the treatment of symptoms of Fragile X Syndrome (FXS). There are currently no FDA approved medications shown to treat FXS. ZYN002 is an experimental treatment. This means that it is not approved by the FDA and must be tested to see if it is an effective treatment.

Drug study, Phase [/2/,/ /3/]
Any, age 3 to 18 years old

Telehealth study about a parent-implemented language test for individuals with Autism Spectrum Disorder

Estudio de telesalud sobre una prueba de lenguaje aplicada por los padres en el hogar para personas con Trastorno del Espectro Autista

We are now recruiting parents along with their sons/daughters with ASD for a new study! The study aims to teach parents to administer a spoken language test to their sons/daughters in their homes via telecommunication technology (i.e. Skype). We also will be adapting the language test for use with Spanish-speaking families. Therefore, we are recruiting both families who primarily speak Spanish as well as families who primarily speak English with their children. Estamos reclutando padres junto con sus hijos/as con TEA para un nuevo estudio! El objetivo del estudio es enseñar a padres a dar una prueba de lenguaje a sus hijos/hijas en sus hogares a través de las tecnologías de telecomunicaciones (ej., Skype). También adaptaremos la prueba al español. Por lo tanto, estamos reclutando tanto a familias que hablen principalmente inglés en casa con sus hijos como a familias que hablen principalmente español con sus hijos.

outcome measures/ medidas de resultado
Any, age 6 to 23

Study on Language Development in Young Adults with Fragile X Syndrome

The goal of the study is to learn more about how certain abilities (e.g. memory), certain types of experiences (e.g. interactions with family), and biology affect language abilities in adulthood for both males and females with fragile X syndrome. We are also interested in understanding how these factors and language/literacy skills affect the abilities of these young adults to function independently. Such information will help us suggest ways to improve instruction, therapy, and support to help youth fragile X to successfully transition from school to the demands of adult life.

Behavioral
Any, age in, entering, or just out of last year of HS

A Study of the Experimental Medicine OV101 For Fragile X Syndrome

Volunteer for research at UC Davis and contribute to discoveries that may improve health care for you, your family, and your community!

We invite you to take part in a research study because your child has a rare genetic disorder called Fragile X syndrome (FXS). You are being asked to give permission for your child to take part in the study. If you are a parent/legally authorized representative (LAR), you are being asked to take part in this study as detailed in this consent form. Before you decide if you want to take part, it is important for you to understand why the research is being done and what it will involve. Please read the following information carefully and discuss it with friends, family and physician if you wish. The study doctor or study staff will also explain the study to you.

Drug study, Phase 2
Male, age 13 to 22 years old

In-Home Autism Study

Are you a parent of a child with Autism?

Researchers at the UC Davis MIND Institute are collaborating with the Hartwell Foundation, Stanford University and Case Western University to reach thousands of families who are managing the challenges of caring for a child with an Autism Spectrum Disorder diagnosis. As its name implies, Autism Spectrum Disorder (ASD) represents a spectrum of symptoms, behaviors and associated features that medical science generally refers to as autism. It is the goal of the "Kids First" initiative to create a detailed classification of ASD that will more accurately reflect each individual's behavior and personality. With this new approach, researchers will be able to dig beyond the surface features of the disorder, to enact personalized, targeted approaches for care and interventions that will be more successful than what is available today.

survey
Any, age 1-17
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