A collaborative research program between NewYork-Presbyterian Hospital, Weill Cornell Medicine, and Columbia University Medical Center
Current Studies
Conducted at the CADB Medicine Research Program
Pimavanserin Study
Currently Enrolling
The CADB Medicine Program at the Center for Autism and the Developing Brain is
recruiting individuals with autism 16- 40 years of age to participate in
the Pimavanserin study.
The purpose of this study is to see if a medication called Pimavanserin can help improve behavioral inflexibility and rigid- repetitive behaviors that are associated with Autism Spectrum Disorder (ASD).
Currently, Pimavanserin is approved for treatment of hallucinations and delusions associated with Parkinson's disease. The medication is now being studied in those with ASD to see its effect on inflexible behaviors as well as rigid thinking, which means its use in this study is considered investigational.
The study will take place over a ~ 10 week period. There are two phases in the study as described below.
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The first 2 visits of the study are what is called Double- Blind phase. Like flipping a coin, participants have the 50/50 chance to receive the active medication (Pimavanserin) or a placebo pill (like a sugar pill with no effect).
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For the first 2 visits of the study, you will take one pill in clinic prior to assessments.
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The last 6 weeks of the study is what is called Open-Label phase. This means that everyone is on the active medication to be taken daily.
In total, participation in the Pimavanserin study will take ~10 weeks, and will include 5 visits to the study clinic to meet with study staff to access safety and complete study material. Participants must be diagnosed with ASD or be suspected of having ASD to enroll.
Participants will not have to pay for any study related treatments, lab tests, or assessments.
For more information, please email us at cadbmedicine@cumc.columbia.edu or call 914-997-5587.
Propranolol Study
Currently Enrolling
The CADB Medicine Program at the Center for Autism and the Developing Brain is
recruiting individuals with autism 12- 40 years of age to participate in
the Propranolol study.
The purpose of this study is to test a medication, named propranolol, which is primarily used in treating high blood pressure, and has also been used to treat migraines and performance anxiety. We want to see if propranolol is effective as a treatment to help improve aggression, irritability and challenging behaviors in adolescents and adults with autism spectrum disorder (ASD). To determine this, participants will be randomly assigned to take the study medication (propranolol) or a placebo pill (dummy drug with no active treatment) for 12 weeks. At the end of the 12 weeks, participants will be given the option to take active study medication for 12 more weeks.
In total, participation in the Propranolol study will take 13-26 weeks, may include up to 3 visits to the study clinic, and weekly video calls with the study doctors to monitor your loved one’s health, ensuring safety and tolerability. Participants must be diagnosed with ASD to enroll.
Participants will not have to pay for any study related treatments, lab tests, or assessments.
For more information, please email us at cadbmedicine@cumc.columbia.edu or call 914-997-5587.
Previous Studies
Conducted at the CADB Medicine Research Program
The IRIS Study
Closed
The CADB Medicine Program at the Center for Autism and the Developing Brain is
recruiting individuals with autism 12- 17 years of age to participate in our study called
the IRIS Study.
The purpose of this study is to test an investigational treatment, named ML-004. The investigational medicine works on the Serotonin system, which is thought to shape social behaviors. We want to see if this medicine Is effective as a treatment to help improve social deficits associated with ASD (Autism Spectrum Disorder). To determine this, participants will be randomly assigned to take the investigational treatment or a placebo pill.
In total, participation in the IRIS study will take up to 26 weeks and includes up to 10 visits to the study clinic, plus a safety follow-up call. If you participate in the study, your child's health will be monitored to ensure safety and tolerability. Participants must be diagnosed with or be suspected to have ASD to enroll.
Participants will not have to pay for any study related treatments, lab tests, or assessments. Participants and study partners will be paid $100 each per visit for their time within this study. Travel expenses up to $40 can also be reimbursed.
For more information, please email us at cadbmedicine@cumc.columbia.edu
The Y202 Study
Closed
In collaboration with Yamo Pharmaceuticals, LLC, the CADB Medicine Research Program is currently recruiting for a study of a medication to potentially target the core deficits in social communication and interaction in children and adolescents with ASD (autism spectrum disorder) between the ages of 12-21 years old. Prior research indicates that individuals with ASD may have overactive dopaminergic and noradrenergic systems, which are involved in mediation of mood, cognition, reward, irritability, anxiety. The trial medication, L1-79, may help to regulate these systems, which may help with the social communication deficits associated with ASD.
We are looking for participants between the ages of 12 to 21 with a diagnosis of ASD to participate in this 34-week study trial that involves 10 site visitations. Participants will be reimbursed for each visit and will receive evaluations and feedback at no cost to them. This program is directed by Dr. Jeremy Veenstra-VanderWeele as a collaboration between Weill Cornell Medicine, the Research Foundation for Mental Hygiene, and Columbia University Medical Center at the NewYork-Presbyterian Hospital Center for Autism and the Developing Brain (CADB).
For more information, please email us at cadbmedicine@cumc.columbia.edu
TD JAKE Study
Closed
The CADB Medicine Research program, in collaboration with Janssen Research & Development, LLC, was recruiting healthy individuals between the ages of 13-35 for our TD JAKE study. The JAKE system or Janssen Autism Knowledge Engine is a set of research tools used to measure and identity traits associated with ASD (Autism Spectrum Disorder) using an EEG (electroencephalogram), ECG (electrocardiogram) and eye tracker. We are looking for healthy individuals with no diagnosis of ASD to take part in this study to gain information on how the JAKE system works with typically developing individuals.
The program is directed by Dr. Jeremy Veenstra-VanderWeele as a collaboration between Weill Cornell Medicine, the Research Foundation for Mental Hygiene, and Columbia University Medical Center at the NewYork-Presbyterian Hospital Center for Autism and the Developing Brain (CADB).
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Compensation will be provided up to 100$
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For more information, contact us at cadbmedicine@cumc.columbia.edu
The L16HTHOUSE Study
Closed
The CADB Medicine Research Program is recruiting for a study of a medication to potentially target communication deficits in children ages 5-17 with a deletion on Chromosome 16p11.2. In collaboration with Clinical Research Associates, LLC, the medicine, Arbaclofen, is being examined as a possible treatment option for behavioral symptoms caused by 16p11.2 deletion. Deletion on chromosome 16p11.2 has been linked to neurodevelopmental disabilities such as ASD, Fragile X Syndrome and other intellectual disabilities. Chromosome 16p deletion is hypothesized to effect metabotropic glutamate receptor subtype 5 (mGluR5) and cause elevated signaling that may lead to communication deficits. Arbaclofen works to help indirectly regulate mGluR5.
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We are looking for participants between the ages of 5 to 17 with a diagnosis of 16p11.2 (BP4-BP5) to participate in this 27-week trial that involves 4 site visitations. Participants will be reimbursed for each visit, including a travel reimbursement, and will receive evaluations and feedback at no cost to them. This program is directed by Dr. Jeremy Veenstra-VanderWeele as a collaboration between Weill Cornell Medicine, the Research Foundation for Mental Hygiene, and Columbia University Medical Center at the NewYork-Presbyterian Hospital Center for Autism and the Developing Brain (CADB).
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For more information, please email us at cadbmedicine@cumc.columbia.edu
The Autism Biorepository
Closed
For individuals with autism and their biological family members
Our program at the Center for Autism and the Developing Brain is recruiting individuals with autism from 1 to 40 years of age and their biological family members from 1 to 70 years of age to participate in our Autism Biorepository. The purpose of this study is to determine genetic factors that influence the development of autism.
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Participants will be given a travel reimbursement of $25 for 2 family members, $30 for 3 family members, and $40 for 4 or more family members.
To participate in the Autism Biorepository, please contact us at:
Email: cadbmedicine@cumc.columbia.edu
Phone: (914) 997-5587
Envision Study
Closed
The CADB Medicine Research Program is evaluating a potential medicine that targets the endocannabinoid system for autism-related symptoms in adolescents and adults. In collaboration with Janssen Research & Development, LLC, we are evaluating the effects of this medication on social communication problems, as well as on repetitive behaviors. The potential medicine, JNJ-42165279, blocks an enzyme called fatty acid amide hydrolase (FAAH), which breaks down anandamide, a naturally occurring endocannabinoid. Participation in this study will last approximately 12 weeks with 8 total visits to our clinic. We are looking for participants aged 13-35 years old with a diagnosis of Autism Spectrum Disorder (ASD) and a caregiver who would be willing to complete study activities. Participants will be compensated for each study visit and will receive evaluations and feedback. The CADB Medicine Research Program is dedicated to helping people with Autism Spectrum Disorder (ASD). The program is directed by Dr. Jeremy Veenstra-VanderWeele as a collaboration between Weill Cornell Medicine, the Research Foundation for Mental Hygiene, and Columbia University Medical Center at the NewYork-Presbyterian Hospital Center for Autism and the Developing Brain (CADB).
Compensation will be $100 for caregivers and $81 for participants per visit.
For more information, please email us at cadbmedicine@cumc.columbia.edu
The FX-Learn Study
Closed
For Toddlers with Fragile X Syndrome
The CADB Medicine Research Program is conducting a study for children with Fragile-X Syndrome from 32 months to 6 years of age to participate in our study called FX-LEARN. The purpose of this study is to find out if the drug AFQ056, made by the pharmaceutical company Novartis, is safe and has beneficial effects on language learning in children who have Fragile-X syndrome (FXS). The study also aims to find out if a structured language intervention can help children with Fragile-X syndrome communicate better.
The CADB Medicine Research Program is no longer recruiting participants for the FX-Learn Study.
The aV1ation Study
Closed
For Children and Adolescents with Autism Spectrum Disorder
We recently completed the Aviation study, sponsored by Hoffman La Roche. The purpose of this study was to test an investigational medicine, called Balovaptan, that blocks a hormone receptor in the brain linked to the control of socialization, stress, anxiety and aggression. We investigated whether this medicine is effective as a treatment to help improve social functioning in children with ASD. To determine this, participants were randomly assigned to take the investigational drug or a placebo pill. Participation lasted up to 39 weeks and will involve regular visits to the Center for Autism and the Developing Brain. This allowed the study team to assess participants general health, social communication skills and social interaction skills.
Study of Oxytocin in Autism to Improve Reciprocal Social Behaviors (SOARS-B)
Closed
For Children and Adolescents with Autism Spectrum Disorder
The CADB Medicine Research Program recruited participants from 3–17 years of age for a clinical trial to evaluate a medication called oxytocin for use in children and adolescents with autism spectrum disorder (ASD). We wanted to see if this medicine was effective as a supplemental treatment to help improve social functioning in children with ASD. SOARS-B was sponsored by the National Institute of Health (NIH) and enrolled approximately 300 participants at 6 centers across the United States.
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