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Clinical Research Studies
Study Title and Description
Age
Diagnosis
Study ID. 173: Infant Sib Phase III Study
Research subjects needed for a study of early development that follows babies from infancy through their third birthday. We
are interested in learning more about early social, language, cognitive, motor, and attention development to identify autism
and ADHD earlier as well as understand the range of development in typically developing children. We are enrolling babies
9-months-old or younger with at least one older sibling diagnosed with ASD, ADHD or Typical Development. For more
information about this study, contact Alesha Hill at (916) 703-0297 or [email protected].
Study ID. 145: (PATH) Parents and Toddlers at Home
The purpose of this study is to test an adapted version of the Parent Delivered Early Start Denver Model with parents of 12-30
month old children at risk for or diagnosed with autism spectrum disorder. State-of-the-art technology and evidence-based
coaching approaches will be combined to help parents deliver frequent and varied teaching opportunities throughout their
daily interactions with children, as well as to evaluate their satisfaction across children's learning goals. For more information
about this study, contact Deeniece Hatten at (916) 703-0468.
Study ID. 157: Statistical Learning in Infants with Early Signs of Autism
The purpose of this project is to better understand the language impairments seen in children with autism by examining their
ability to detect statistical regularity in speech. For more information about this study, contact Ryan Barry at (530) 747-3808.
9 months
with at least
one older
sibling
Autism Spectrum
Disorders, ADHD or
Typical Development
12 to 30
months
Autism Spectrum
Disorders
walking and without
sensory impairments or
known genetic conditions
15 to 33
months
Autism
Study ID. 181: GAIN Study (Girls with Autism - Imaging of Neurodevelopment)
Autism is much more common in boys than girls, and girls are often underrepresented in research studies. As a result, little is
known about whether there are differences in brain alterations between boys and girls with ASD. The goal of the GAIN study
is selectively recruit females with ASD to enrich the existing Autism Phenome Project cohort and to evaluate sex differences in
autism. For more information about this study, contact Michelle Huynh at (916) 703-0410.
Study ID. 9: (CHARGE) Childhood Autism Risks from Genetics and the Environment
This study is looking at factors in the environment that are associated with Autism and other neurodevelopmental disorders in
some children and families. Approximately 1,000 children will participate. Parents and siblings of each child are also asked
to participate. Please note that children with Autism Spectrum Disorder or developmental delay must be clients of Alta, North
Bay, Valley Mountain, or East Bay Regional Center. For more information call (866) 550-5027 or Matt Ponzini at (916)
703-0434.
Study ID. 150: A Controlled Trial of Sertraline in Young Children with Fragile X Syndrome
This study is a control trial of sertraline (Zoloft) in fragile X syndrome children aged 2 years to 5 years 8 months old. The trial
is six months long, and each participant will receive a series of tests at both the beginning and end of the study. The
researchers hope to show improvements in language and a decrease in autistic symptoms. For more information about this
study, contact Jonathan Polussa at (916) 703-0477.
Study ID. 176: Probiotics
This study is a double-blind crossover trial of a probiotic in autism patients between the ages of two and fourteen years old
with gastro-intestinal problems. The trial is three and a half months long and will include four visits to the UC Davis MIND
Institute. Participants will come for an initial screening visit that will include IQ testing, questionnaires, a blood draw, and a
medical exam. Participants will then be asked to take the study drug or placebo for six weeks, stay off for two weeks, and
then switch to the other study arm for an additional six weeks. For more information about the study, contact Jonathan
Polussa at (916) 703-0477.
Study ID. 182: Parenting and Adaptive Functioning in Children
This study focuses on skill development in children with and without chromosome 22q11.2 deletion (VCFS/DiGeorge)
syndrome (22q). We are interested in studying how children solve problems, manage challenging tasks, and how parents
are involved in that process. In addition, we hope to learn from both parent and child’s bodily states during these tasks. For
all participants involved in this study, children will undergo developmental testing (IQ), a history and physical examination,
and complete interviews or questionnaires. Parents will complete questionnaires about parenting and their child’s behavior.
Testing can usually be completed in a single four hour session.
For more information about this study, contact Courtney
Durdle (916) 703-0409.
Study ID. 5: Genotype-Phenotype Relationships in Fragile X Families
We are conducting medical and psychological assessments for immediate family members of persons with Fragile X
Syndrome. The study focuses on identifying areas of specific deficits. Cognitive and neuropsychological testing, autism
assessments, medical exams, and blood draws will be completed over a 2-3 day period. For more information about this
study, contact Laura Berkowitz-Sutherland at (916) 703-0301.
2 to 3 ½
years
Females
Autism Spectrum
Disorder, Typical
Development
2 to 5
years
Autism Spectrum
Disorders,
Developmental Delays
(without ASD)
2 to 5
years
Fragile X Syndrome
2 to 11
years
Autism Spectrum
Disorders (Autism,
Asperger Syndrome)
4 to 11
years
Chromosome 22q11.2
Deletion Syndrome,
(DiGeorge/VCFS)
5 to 100
years
Fragile X Syndrome or
Typical Development
Last Updated 10/15/2014
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Study Title and Description
Age
Diagnosis
Study ID. 175: (ABC) The Attentional Behavior and Cognitive Control
The purpose of this study is to learn more about the behavior of children and adolescents with ASD when they think and play.
Participants will come to the UC Davis MIND Institute for one 1.5-hour visit. Parent will complete several questionnaires.
Participants will complete several questionnaires, assessments and play computer games. For more information about this
study, contact Leslie Gilhooly at (916) 734-7801.
6 to 15
years
Autism Spectrum
Disorder Typical
Development
Study ID. 170: (ELS) Expressive Language Sampling in Down Syndrome and Fragile X Syndrome
The goal of this study is to learn more about how samples of spoken language can be used to measure change over time in
the spoken language, problem solving, and behavior of individuals with genetic syndromes. If you decide that you and your
son or daughter would like to be in this study, we will ask you to visit one of the study sites three times over two years. At each
visit, we will collect a sample of your son or daughter's speech as s/he interacts with an examiner in three different settings: a
conversation, looking at a picture book, and participating in a series of interactive activities with an examiner. For more
information about this study, contact Lauren Bullard at (916) 703-0484.
Study ID. 62: Executive Control of Attention in Chromosome 22q11.2 Deletion Syndrome
Many individuals with chromosome 22q11.2 deletion syndrome (VCFS/DiGeorge) score lower on tests of math and similar
thinking abilities compared to how they score on tests of verbal abilities. We are studying the brain and how it produces this
kind of thinking. Once we know more we hope to find ways to reduce the learning problems that some children have. For
more information about this study, contact Courtney Durdle at (916) 703-0409.
Study ID. 113: Hormonal Indices of Stress Reactivity and Coping in Children with Chromosome 22q11.2 Deletion Syndrome
The goal is to further characterize the 22q11.2 Deletion Syndrome endophenotype by examining the impact of stress and
anxiety on immunity as well as brain development and function. The study compares typically developing children with children
diagnosed with 22q11.2 Deletion Syndrome. For more information about this study, contact Courtney Durdle at (916) 7030409.
Study ID. 114: Spatiotemporal Cognition in Chromosome 22q11.2 Deletion Syndrome
This study focuses on the problems that some children have with thinking and reasoning about time, space, numbers and
related areas of learning. The study also focuses on the brain and how it produces this kind of thinking. The long-term goal is to
develop interventions to reduce the learning problems that children with chromosome 22q11.2 deletion Syndrome and other
developmental disorders have. For more information about this study, contact Courtney Durdle at (916) 703-0409.
Males and
Females 6
to 23 years
Fragile X Syndrome or
Down Syndrome
7 to 14
years
DiGeorge Syndrome or
Typical Development
7 to 14
years
Chromosome 22q11.2
Deletion Syndrome or
Typical Development
Study ID. 174: (IMPACT) Identifying Markers for Treatment Response to Cognitive Training in Autism Spectrum Disorders
Participants will complete 5-6 weeks of in-home computerized cognitive training (about 25 minutes per day with weekly coach
check-ins by phone or email). Participation also includes cognitive and behavioral evaluations during 2-3 visits (about 2 hours
each), 1 before cognitive training, and 1-2 after. Qualified MIND Institute researchers will visit your home, or you may come to
the MIND Institute with your child for visits. Families will receive compensation for their time and feedback on their child's
progress and assessment results. For more information about this study, please contact Songpoom Benyakorn & Catrina Calub
at (916) 703-0294 or email us at [email protected].
Study ID. 165: Cognitive Training for Fragile X Syndrome
The goal of this study is to determine if a computer-based and game-oriented training program will enhance the working
memory skills of children and adolescents with fragile X syndrome (FXS). This paradigm is being tested as a potential
intervention to improve certain cognitive and behavioral skills in FXS, such as paying attention and resisting distractions. For
more information about this study, contact the Hessl Lab at (916) 703-0461.
Study ID. 141: Gesture Processing in Autism Spectrum Disorders and Typical Development
The goal of this study is to learn more about gesture processing and production in autism spectrum disorders (ASD).
Impairments in gestural communication are central to a diagnosis of autism, yet little is known about differences in the neural
systems that underlie gesture use. This study assesses participants' gesture production and imitation skills, and uses fMRI to
examine neural activation patterns in typically developing children and children with ASD when they are presented with videos
demonstrating gestures. It will examine relationships between the response patterns from fMRI, participant’s performance on
neuropsychological testing batteries and participant's gesture imitation performance. For more information about this study,
contact Jennifer Pokorny at (530) 747-3808.
Study ID. 179: Parent Implemented Spoken Language Intervention
The goal of this project is to teach each mother strategies which can be used to support spoken language development in their
child with fragile X syndrome. The study will involve up to 2 visits to the UC Davis MIND Institute (located in Sacramento
California) and approximately 12 weekly intervention sessions. The weekly intervention sessions will be conducted via distance
video-teleconferencing using SKYPE. Compensation for travel-r elated expenses will be provided in accordance with UC Davis
policies. For more information about this study, contact Lauren Bullard at (916) 703-0484.
Study ID. 143: Cognitive Precursors of Language Impairment in Down Syndrome
The goal of this five-year study, funded by the National Institute of Child Health and Human Development, is to investigate how
certain types of memory and learning challenges affect the development of language in adolescents and young adults with
Down syndrome (DS) and other intellectual disabilities. The project is focused on adolescents and young adults with DS and
other intellectual disabilities who are between the ages of 10 and 21 years. For more information about this study, contact
Alicia Cox at (916) 703-0226.
8 to 17
years
Last Updated 10/15/2014
7 to 14
years
Chromosome 22q11.2
Deletion Syndrome,
(DiGeorge/VCFS)
Klinefelter Syndrome or
TrisomyX/Triple X
Syndrome or Typical
Development
Autism, either with or
without Fragile X
Syndrome
8 to 18
years
Fragile X Syndrome
9 to 15
High Functioning Autism
or Asperger Syndrome
or Typical Development
10 to 17
years
Fragile X Syndrome
10 to 21
years
Down Syndrome (DS)
participants. Intellectual
disabilities; Fragile X
Syndrome, Williams
Syndrome or 22q11.2
Deletion
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Study Title and Description
Study ID. 163: Down Syndrome Phenotype Project
We are recruiting families for a research project designed to identify the genetic and medical factors affecting cognition and
language in individuals with Down syndrome. This project is a collaboration with researchers at John Hopkins University,
University of Arizona, Oregon Health and Sciences University, and Emory University. This research is approved by the
University of California, Davis Institutional Review Board for the Protection of Human Participants. For more information and to
find out if your child is eligible, contact, Lauren Bullard or by email [email protected] or telephone (916)
703-0484.
Study ID. 137: AFQ14: Targeted Treatment of an mGluR5 Antagonist for Adolescents with Fragile X Syndrome
The goal of this study is to evaluate the safety and efficacy of 3 doses of AFQ056, an mGluR5 antagonist used to treat
problematic behaviors such as impulsivity, anxiety, and mood volatility in adolescents 12 to 17 years of age with fragile X
syndrome. For more information about this study, contact Aisha Lott at (916) 703-0472.
Study ID. 161: (MINT) Mapping Impulsivity’s Neurodevelopmental Trajectories
The goal of this longitudinal study is to characterize typical neurodevelopment of cognitive control and reward related function
during adolescence and early adulthood and assess its relationship with self‐control in ADHD and typicals. It will also track
how underlying behaviors associated with self‐control and impulsivity are associated with academic and educational
performance. fMRI, behavioral and educational assessments will be used. For more information about this study, contact
Amrita Ramakrishnan at (916) 703-0294.
Study ID. 159: (LEIA) Lisdexamfetamine Effect in ADHD
This is a randomized, double-blind, placebo-controlled study. Patients will receive either a placebo or the study drug. The goal
is to identify the mechanism of action of lisdexamfetamine (LDX) on the neural systems involved in ADHD and the relationship of
this action to ecologically-valid clinical outcomes in adolescents and young adults with ADHD. For more information about this
study, contact Erin Calfee or Arthur Hartanto at (916) 703-0294.
Study ID. 152: Language Development in Fragile X Syndrome and Autism Spectrum Disorder
We are recruiting families for a longitudinal research project designed to investigate the language learning difficulties of males
who have fragile X syndrome and males who have autism. For more information and to find out if your child is eligible, contact
Alicia Cox by email [email protected] or telephone (916) 703-0226.
Study ID. 177: A multi-center, randomized, double-blind, placebo-controlled study of the efficacy, safety and tolerability of
RO5186582 in adults and adolescents with Down syndrome
You are invited to take part in a research study of an experimental oral medication (taken by mouth) called RO5186582 that is
being studied by Roche and the MIND Institute for treating Down syndrome. We hope to learn about the safety of the medicine
in people with Down syndrome, how well your body manages the medicine (tolerability), and if it can help learning, memory
and language skills in people with Down syndrome. We expect that you will be in this research study for about 10 months.
You will be randomized to either active medication or placebo. This study will require you to attend 10 clinic visits (including
the screening and follow-up visits).
Study ID. 184: Alcobra Study
This study will evaluate the efficacy of MG01CI (Metadoxine Extended-release) once daily compared with placebo in the
treatment of symptoms of FXS in adults and adolescents as measure by the inattentive subscale of Attention Deficits Hyperactivity
Disorder (ADHD) Rating Scale (ADHD RS-IV). For more information and to find out if your child is eligible, contact Lindsey
Partington at (916) 703-0471
Study ID. 78: (MARBLES) Markers of Autism Risk in Babies-Learning Early Signs
This study enrolls women who have a child diagnosed with autism spectrum disorder and who are currently pregnant or who
plan to become pregnant in the near future. We will learn everything we can about their lives in an effort to see whether there
are any risk factors occurring during pregnancy that may be associated with the later diagnosis of autism. The babies will be
followed for 3 years. For more information about this study, contact Tori Galvez at (916) 703-0224.
Study ID. 169: VANILLA Study: Clinical Drug Trial for Autism Spectrum Disorder
The goal of this study is to evaluate the safety, tolerability, and efficacy of 12-week treatment with RO5285119, a
vasopression 1a antagonist, compared with placebo in treating social communication deficits in individuals with ASD as
measured by the SRS-2. This study involves a total of 17 visits in 24 weeks with 24 blood draws, 10 urine samples, 7 ECGs,
medical history review, 7 physical exams, neuropsychological testing, and behavioral questionnaires for both the subject and
subject's parent/caregiver/LAR with minimum of 10 interim visit phone calls. Patients will be required to take 3 capsules, once
daily, in the morning. For more information about this study, contact Lindsey Partington at (916) 703-0471.
Study ID. 171: (TRAX) Longitudinal Study of Brain and Cognition in Fragile X Premutation Carriers
This study examines changes in the brain and cognition associated with aging, in males with and without the fragile X
premutation. The study consists of three 2-day visits over the course of five years, to observe changes in the brain and cognition
occurring over time. The study involves a medical history exam, neuropsychological evaluation, behavioral testing, MRI, and
blood draw. For more information about this study, contact Jessica Famula at (916) 703-0470.
Age
Diagnosis
11 to 25
years
Down Syndrome
with full trisomy 21
12 to 17
years
Fragile X Syndrome
12 to 25
years
ADHD
Typical Development
12 to 25
years
ADHD
15 to 22
years
Autism or
Fragile X Syndrome
15 to 30
years
Down Syndrome
15 to 55
years
Fragile X Syndrome
18 years or
older
Males 18 to
45 years
Autism Spectrum
Disorders
Males 4075 years of
age
With or Without the
Fragile X Premutation
The UC Davis MIND Institute (Medical Investigation of Neurodevelopmental Disorders) is a collaborative international research center, committed to the awareness,
understanding, prevention, care, and cures of neurodevelopmental disorders.
If you need further information regarding our clinical research studies, contact Brenda Shelton at (916) 703-0343
or visit our website at http://mindinstitute.ucdavis.edu.
Last Updated 10/15/2014
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