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The ConnectMe research program is focuses on 6 to 12 year old children who have been diagnosed on the autism spectrum. The international initiative boasts 85 study centers in the United States and 185 worldwide, which makes this study the largest of its kind.1 The program includes three studies that are evaluating the safety, tolerability, and effectiveness of an investigational drug, known as memantine, on social interaction and communication skills in children with autism, Asperger’s Disorder, and Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS).2 Memantine, also known as Namenda, has been utilized to treat Alzheimer’s disease by effectively reducing the moderate to severe symptoms of memory loss and thinking problems.3 If the study’s results are promising, the FDA would likely approve memantine as the first effective drug that targets autism’s core symptoms.1
The ConnectMe research program, which is sponsored by Forest Laboratories, currently consists of three studies. ConnectMe-91, the principal trial, is currently enrolling participants, while ConnectMe-68 and ConnectMe-69 are two follow-up studies that are available for participants in the ConnectMe-91 study that show improvements in their conditions. According to the ConnectMe website, the purpose of the ConnectMe-91 study “is to evaluate the safety and tolerability of the investigational drug in children with autism, Asperger’s Disorder, or PDD-NOS. The ConnectMe-91 study will also identify children who may be eligible to join one or both of the follow-up studies.”2 Specifically, participants in the ConnectMe-91 study will undergo a 2-week screening period, a 6-week period of implementing the investigational dose of the drug based on the participant’s weight, and a 42-week period of taking a dose of the drug that the study doctor deems most appropriate for the participant.2 In the ConnectMe-68 follow up study, participants may take a full dose of the investigational drug, a reduced dose, or a placebo, while all eligible participants will receive the investigational drug in the ConnectMe-69 study.2
The ConnectMe research program is collaborating with the Adolescent and School-age Psychiatric Intervention Research Program (ASPIRE) research program within the University of North Carolina at Chapel Hill. Led by Child and Adolescent Psychiatrist Dr. Linmarie Sikich, the program focuses children and adolescent with a suspected autism, schizophrenia, psychosis, or bipolar diagnosis.4 In addition to the Chapel Hill location, the ConnectMe Initiative is now enrolling study participants in their 80-plus sites in the United States and around the world. Parents wishing to enroll their child into this study must first make sure that their child meets the study’s requirements. There is a helpful study questionnaire for parents to determine if their child meets these requirements. You may want to explore the study location map to see if there is a study center in your area currently enrolling participants before you complete the study questionnaire because, if accepted, you and your child are expected to make 13 visits to the study site over the 50-week period of the study. Memantine has only a few mild side effects, which include dizziness, confusion, headache, and constipation when used on the elderly in combination with another drug to help their symptoms related to Alzheimer’s disease.3 If the child experiences any adverse reaction from the use of the drug, he/she will be released from further participation. Parents can also withdraw their child from the clinical trial at any time. According to ClinicalTrials.gov this study is scheduled for completion in June of 2013.5