Down Syndrome Memantine Follow-up Study
This study will determine if the Alzheimer's disease drug memantine hydrochloride can improve learning and memory in adolescents and young adults with Down syndrome.
|Minimum Age||Maximum Age||Gender||Healthy Volunteers|
|15 Years||32 Years||All||Yes|
- Cytogenetically documented Trisomy 21 or complete unbalanced translocation of chromosome 21 (mosaic Trisomy 21 and partial translocations will be excluded)
- Women of child-bearing potential who are sexually active must use reliable birth control
- Laboratory findings within normal limits or judged clinically insignificant at baseline
- Vital signs within normal limits for age (stable, medically treated hypotension will be allowed)
- Electroencephalogram (ECG) that demonstrates predominately normal sinus rhythm
- Informed consent from participant and his or her representative
- Good general health
- Ability to swallow oral medication
- Reliable caregiver or family member who agrees to accompany participant to all visits, provide information about the participant, and ensure compliance with the medication schedule
- Proficient in English
- Weight of less than 40 kg (about 88 pounds)
- Current psychiatric or neurologic diagnosis other than Down syndrome, such as major depression, schizophrenia, bipolar disorder, autism, Alzheimer's
- Current treatment with psychotropic drugs
- Drug or alcohol abuse or dependence
- Significant suicide risk
- Electroconvulsive therapy or psychotropic drugs or has taken a depot neuroleptic drug within the past 6 months
- Current or expected (within the next 6 months) hospitalization or residence in a skilled nursing facility (may reside in group home or other residential setting with no skilled nursing)
- Active or clinically significant conditions affecting absorption, distribution, or metabolism of memantine, such as inflammatory bowel disease or celiac disease
- Significant allergy to or intolerance of memantine or its ingredients; contraindication to memantine therapy
- Expected to require general anesthesia during the study
- Presence or recent history of seizure disorder (within past 3 years)
- Clinically significant and/or clinically unstable systemic disease (controlled hypothyroidism allowed if on stable dose of medication for at least 3 months; controlled diabetes allowed if HbA1c <8.0% and random serum glucose value of <170 mg/dl)
- Severe infection or a major surgical operation within 3 months prior to screening
- History of persistent cognitive deficits immediately following head trauma
- Donation of blood or blood products less that 30 days before screening, during the study, or 4 weeks after the study
- Significant hearing or visual impairment
- Controls without Down syndrome: history of substance abuse, major psychiatric disorder, attention deficit disorder, or learning disability; Beck Depression Score greater than 10
Memantine is approved to treat memory and thinking problems in people with Alzheimer's disease, but little is known about its effects in people with Down syndrome. Participants in this study will be randomly assigned to take either the study drug or a placebo for 16 weeks.
Participants will undergo a physical exam, laboratory tests, an electrocardiogram (ECG), and tests of memory, learning, and reasoning skills. An EEG will be used to access brain responses to auditory and visual stimuli. A urine sample will be collected and used to freeze cells for potential future studies.
Up to 60 participants will take part in an optional magnetic resonance imaging (MRI) study, aimed at making the EEG study more precise and finding out whether memantine has any significant effect on the structure of the brain. Additionally, researchers will recruit a second control group of 60 age- and gender-matched participants without Down syndrome to ascertain which test results are due to a person having Down syndrome and which are not. This control group will make one EEG and one MRI visit but will not take the study medication.
University Hospitals Case Medical Center
Melissa R Stasko, JD
University Hospitals Case Medical Center
- Alana USA Foundation
|Alberto C. Costa, MD, PhD||Principal Investigator||University Hospitals Case Medical Center|
|Stephen L. Ruedrich, MD||Study Director||University Hospitals Case Medical Center|
|Ana Brandão, MD||Principal Investigator||Sociedade Beneficente Israelita Brasileira Albert Einstein|
|Melissa R. Stasko, JD||216-844-7281||Melissa.Stasko@case.edu|
Phase II Multicenter 16-Week Randomized Double Blind Placebo-Controlled Evaluation of the Efficacy, Tolerability and Safety of Memantine Hydrochloride on Enhancing the Cognitive Abilities of Adolescents and Young Adults With Down Syndrome
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