A non-drug, placebo-controlled study of the efficacy of a computer-based program to improve working memory in adolescents and young adults with Down Syndrome

Research institution: Duke University

Researcher(s): James Heller

Training Program: Cogmed JM

Summary: Individuals with Down syndrome appear to have superior visual memory skills as compared to spatial memory. Memory and executive function deficits of individuals with Down syndrome have been associated with the neurologic impairment of the hippocampus (memory) and frontal lobes (executive function). Nerve densities in these areas of the brain are much less as compared to typically developing peers. The relationship between neurologic function and language deficit in Down syndrome has not been clearly delineated. It has been suggested that the language deficit may be related to and perhaps result from the working memory deficit. However, new brain imagining data suggest that language deficits seen in Down syndrome also may be directly linked to impaired hippocampus function. Recent research suggests that working memory deficits can be improved with computer-based training. In this study researchers propose to investigate whether or not working memory in adolescents and young adults with Down syndrome can be improved with computer-based training.

Aim: Fifteen participants with Down syndrome, ages 11 to 25 years, will be randomly assigned to either adaptive or non-adaptive working memory training. One aim of this study will be to determine if working memory deficits can be improved in adolescents and young adults with Down syndrome. Researchers will also investigate whether there is a differential effect of memory training on visual versus spatial memory and visual-spatial memory versus auditory memory. Another aim of this study is to compare the learning performance profiles of the individuals with Down syndrome to the reported learning profiles of school-age children with ADHD and preschool children. Finally, researchers will attempt to determine if the learning achieved through the computer-based training generalizes to other computer-based and non computer-based assessments of working memory, attention, reasoning and language function.

Randomization and treatment

A total of 60 subjects with symptoms of mild to moderate OA were selected and recruited into the study. Each subject was randomly assigned to the treatment group or placebo group using a randomization table generated using validated computer software CODE; IDV, Gauting, Germany. The randomization codes were secured confidential by the clinical trial pharmacist and statistician. Thirty subjects were allocated each into placebo and Aflapin groups. The subjects in Aflapin group received 50 mg of encapsulated Aflapin ® twice daily, whereas, the subjects in the placebo group received two capsules having similar organoleptic properties including weight, taste, color, odor and feel. Each subject filled a questionnaire, providing details regarding demographics, medical history and nutritional status, at the baseline evaluation and during each follow-up evaluation on days 5, 15 and 30.

Subjects

One hundred and fifty two patients of either gender were selected for screening. They were between 40 and 80 years of age, and had been suffering from unilateral or bilateral OA of the knee according to the criteria of the American College of Rheumatology [20 ] for more than 3 months. After the use of usual medications had ceased for 7 days, the visual analog scale (VAS) score that assessed pain during the most painful knee movement had to be more than 40, and Lequesne's functional index [21 ] had to be over 7 points. Participants had to be able to walk and give both verbal and written information regarding the study. Signed informed consent was obtained prior to entry. Exclusion criteria included an underlying inflammatory arthropathy, hyperuricemia, expectation of surgery in the near future, recent injury in the area affected by OA of the knee, intra-articular corticosteroid injections within the last 3 months, hypersensitivity to NSAIDs, abnormal liver or kidney function tests, major abnormal finding on complete blood count, history of coagulopathies, history of peptic ulceration and upper GI hemorrhage, uncontrolled hypertension, congestive heart failure, hyperkalemia, pregnancy, lactation and malignant tumors.

Research design

This randomized, double-blind, placebo controlled trial was conducted during August 2009 to December 2009. The study protocol was approved by the Institutional Review Board (IRB) of Alluri Sitarama Raju Academy of Medical Sciences (ASRAM), Eluru, Andhra Pradesh, India (Clinical Trial Registration No. ISRCTN69643551).

Study material

Aflapin is a novel synergistic composition containing B. serrata extract selectively enriched with AKBA and B. serrata non-volatile oil. The non-volatile oil was prepared by selective removal of Boswellic acids followed by removing volatiles under high vacuum (PCT application # PCT/IN2009/000505). This composition was standardized to contain at least 20% AKBA.