A Study of Memantine Hydrochloride (Namenda®) for Cognitive and Behavioral Impairment in Adults With Autism Spectrum Disorders
Condition: Autism Spectrum Disorders
MeSH terms: Autistic Disorder; Autism Spectrum Disorder; Child Development Disorders, Pervasive
Intervention: Memantine
Intervention description: Memantine (Namenda®) was approved by the U.S. Food and Drug Administration in 2003 and by the European Agency for the Evaluation of Medical Products in 2002 for the treatment of moderate to severe Alzheimer's disease. Evidence from available treatment trials of memantine in ASD and non-ASD populations of youth and adults strongly suggest that memantine could be an effective agent for the treatment of adults with ASD.
During the 12 weeks of study duration, subjects will be evaluated at weekly intervals for the first 4 weeks and thereafter every 3 weeks. Memantine will be administered in divided dose twice a day in the morning and evening. Titration of study medication will be guided by a forced titration schedule with an option for slower titration or holding at lower dose per clinician judgment. Safety, effectiveness, response and side effects will be evaluated.
Intervention MeSH terms: Memantine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 25.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: No
Keywords: Memantine; Namenda; Autism Spectrum Disorders; Pervasive Developmental Disorders; Adults

Summary:

      The main objective of this study is to evaluate the safety and effectiveness of memantine
      (Namenda®) for cognitive and behavioral impairment in adults ages 18-50 years with autism
      spectrum disorders (ASD). This is an exploratory, 12-week, pilot study, seeking to determine
      whether Namenda is efficacious and well tolerated in the treatment of adults with ASD. The
      study results will be used to generate hypotheses for a larger randomized controlled clinical
      trial with explicit hypotheses and sufficient statistical power.
    

Eligibility criteria:

        Inclusions

          -  Male and female outpatients 18-50 years of age.

          -  Participants must have DSM-IV-TR diagnosis of PDD and displaying PDD symptoms with at
             least moderate impairment (SRS score ≥ 85 and CGI-PDD ≥ 4).

          -  Fulfills diagnosis of autism spectrum disorders by meeting DSM-IV-TR PDD diagnostic
             criteria of autistic disorder (with the exception of a total lack of spoken language),
             Asperger's disorder, or PDD-NOS as established by clinical interview and confirmed by
             DICA-R PDD module.

          -  Subjects and/or their legal representative must have a level of understanding
             sufficient to communicate intelligently with the investigator and study coordinator,
             and to cooperate with all tests and examinations required by the protocol.

          -  Subjects and/or their legal representative must be considered reliable reporters.

          -  Each subject and/or their authorized legal representative must understand the nature
             of the study. The subject and/or their legal representative must sign an informed
             consent document.

          -  Subject must be able to participate in mandatory blood draws.

          -  Subject must be able to swallow pills.

          -  Subjects with mood, anxiety, or disruptive behavior disorders will be allowed to
             participate in the study provided they do not meet any exclusionary criteria.

        Exclusions

          -  IQ < 85.

          -  Total lack of spoken language.

          -  DSM-IV-TR PDD diagnoses of Rett's disorder, or childhood disintegrative disorder.

          -  Clinically unstable psychiatric conditions or judged to be at serious suicidal risk.

          -  Active symptoms of anorexia or bulimia nervosa

          -  Current diagnosis of a psychotic disorder or unstable bipolar disorder.

          -  History of recent or current (past 30 days) clinically significant depressive or
             anxiety disorder that warrants treatment.

          -  Current diagnosis of schizophrenia.

          -  History of substance use (except nicotine or caffeine) within past 3 months

          -  Serious, stable or unstable systemic illness including hepatic, renal,
             gastroenterological, respiratory, cardiovascular (including ischemic heart disease),
             endocrinologic, neurologic, immunologic, or hematologic disease.

          -  Subjects with severe hepatic impairment (LFTs > 3 times ULN) and those with severely
             impaired renal function (eGFR < 30).

          -  Subjects with genitourinary conditions that raise urine pH (e.g., renal tubular
             acidosis, severe infection of the urinary tract).

          -  Uncorrected hypothyroidism or hyperthyroidism.

          -  Subjects with untreated and/or unstable diabetes.

          -  Non-febrile seizures without a clear and resolved etiology.

          -  Pregnant or nursing females.

          -  Known hypersensitivity to memantine.

          -  Severe allergies or multiple adverse drug reactions.

          -  A non-responder or history of intolerance to memantine, after treatment at adequate
             doses as determined by the clinician.

          -  Investigator and his/her immediate family defined as the investigator's spouse,
             parent, child, grandparent, or grandchild.