Intelligent Refrigerated Automatic Storage System

Period of Performance: 09/30/1992 - 09/29/1993

Unknown

Phase 2 SBIR

Recipient Firm

Automated Control Systems, Inc.
Orem, UT 84058
Principal Investigator

Abstract

An advanced Phase II prototype for a computer-controlled Intelligent Refrigerated Automatic Storage System (IRASS) for medical laboratories will be developed. The system will build on the features of the Phase I project: a database to track storage/retrieval/discard of specimens, bar code reading for specimen identification, robotic hardware for movement of specimens. Additionally extensive safety engineering, an advanced user- friendly interface incorporating text windowing and advanced input devices, a smart loading platform, optimization of motion control, hooks for communications with laboratory computers, specimen disposition logic and fault tolerance will be provided. At the end of the Phase II trial, an extensive field evaluation will take place in an actual clinical laboratory setting. This system has the potential of reducing labor costs required for the storage/retrieval of specimens, increasing test reliability by improved specimen identification, and decreasing the risk of infection for laboratory workers. Phase II will include extensive evaluations of software and hardware necessary before market release of a sophisticated IRASS, GRANT-R01MH48759 This is a proposal for a random assignment, double-blind, placebo- controlled clinical trial of carbamazepine in 66 probable and possible AD outpatients with clinically significant behavioral disorders. The duration of study is six weeks with a 10 to 7 day screening period (run-in). Subjects will be assessed for efficacy at biweekly intervals using validated instruments by raters blind to treatment condition. A clinical monitor who is open to medication status will evaluate subjects weekly to enhance safety. Subjects originally assigned to placebo will be offered an open six week trial of medication under similar study conditions. After the six week trial, there will be an open, uncontrolled, continuation phase of 24 week's duration to assess safety, drug autometabolism, and continuing efficacy. Patients will be seen at monthly intervals for follow-up. The objective of this study is to compare carbamazepine (400 to 300 mg/d) to a placebo control in terms of efficacy and side effects in treating agitated AD patients. Measures of efficacy include the Brief Psychiatric Rating Scale (BPRS), Clinical Global Improvement Scale (CGI), Hamilton Rating Scale for Depression, Relatives' Assessment of Global Symptomatology-Elderly (RAGS-E), the Physical Self-Maintenance Scale and Instrumental Activities of Daily Living (PSMS/IADL). The primary criterion for clinical response is a > 30% improvement on the agitation factor of the BPRS, and a 'much improved' rating on the CGI. A minimum effect size for carbamazepine is defined (r=0.18). A secondary objective is to replicate a prior observation that platelet 3H- imipramine binding B max is decreased, and MAO activity is relatively decreased in Alzheimer's patients with symptomatic behaviors compared to Alzheimer's disease patients without symptomatic behaviors.