Clinical Neuroscience

AMUN

Translation from well established animal tests into human clinical studies.
Test of spatial learning and memory in humans:

  • Sensitive for cognitive changes already in early disease stage
  • Suitable to detect treatment effects
  • Independent from language
  • No ceiling effect
  • Easy and fast to apply


Testing in real version arena
The development of drugs for dementia has been frustrated by a lack of predictive validity from preclinical to clinical effects. Memory paradigms used with human study participants typically feature tests of episodic verbal memory, paired associative learning or visual recognition Memory.These tasks are very different to the memory paradigms employed in rodents. We have sought to improve the predictive power of preclinical findings by creating a human analogue of the well-known Morris Water Maze.

As safety is the primary endpoint of a Phase I clinical trial you would like to have the strong pharmacovigilance team of NeuroScios. In addition Neuroscios is able to set up a Data and Safety Monitoring Board (DSMB) to ensure periodic medical review and ensure subject safety – and guarantees you the opinion of true experts.

AMUNET

Translation from well established animal tests into human clinical studies.
Test of spatial learning and memory in humans:

  • Sensitive for cognitive changes already in early disease stage
  • Suitable to detect treatment effects
  • Independent from language
  • No ceiling effect
  • Easy and fast to apply

Testing of spatial memory ability
AMUNET, the computerized test for spatial memory was designed for use with elderly subjects who have no previous computer experience. AMUNET is based on the AMUN real-space tests. Performance on the computer and arena versions of the task are highly correlated. In the AMUNET task the participant is required to move a pointer on the touch-screen or a mouse pointer in a map view of the arena. Currently we offer two versions, one for patients with mild cognitive impairment and very mild dementia, the second one is designed for use in mild to moderate dementia.

Memory paradigms used with human study participants typically feature tests of episodic verbal memory, paired associative learning or visual recognition Memory.These tasks are very different to the memory paradigms employed in rodents. We have sought to improve the predictive power of preclinical findings by creating a human analogue of the well-known Morris Water Maze.

Neuro Imaging

  • Screening,Safety Imaging and Biomarkers
  • Standardisation Support and Management
  • Central Reading is the only option to avoid inconsistencies and bias
  • Independent Reviewers with trial reading expertise
  • Single Method measurements
Radiologic Imaging has become more important in Neuroscience Clinical Trials, as Pharma/Biotech trial protocols show an increase of endpoints that are related to Medical Imaging. An Imaging endpoint is often not listed as the primary endpoint, is commonly listed as secondary endpoint or is intended for a subgroup of subjects. Regulatory agencies are more frequently demanding that Pharma-Research includes Radiologic scans. The Imaging is performed for screening, safety monitoring and as a biomarker for trial drug activity (disease staging/efficacy). In general the Radiologic Imaging is MRI, PET or CT (or a combination of those modalities). Standardisation is the key for making sure that image review and measurements guarantee comparable datasets. NeuroScios offers 13 years of experience in standardisation in multiple site trials.

This includes the following services:
  • Protocol development support / Imaging Protocol Consultancy
  • Site training (Technologists and Radiologists)
  • Image collection, Quality Control and Central Reading/ measurement services
  • Third party collaborations or multiple imaging vendor management/oversight
  • Data exports and statistical analysis support
 

Neurological testing

The drug development for AD is characterized by continuous failures to show clinical effects and improvement of cognitive function since more than 10 years. Enormous financial and research effort has put into the development of new compounds and in spite of sometimes encouraging data from Phase II clinical testing, the final proof of efficacy failed. Have the wrong compounds been selected for the clinical development? – Most likely, yes!

A reason could be the use of wrong instruments to investigate cognitive effects in early trials. Almost all new substances underwent intensive animal testing in the most widely used cognitive paradigm, the Morris water maze, assessing spatial orientation. How to translate these findings in to human application?

Our experts have  more than 50 years’ experience of Alzheimer’s disease and other cognitive disorder clinical drug trials, gained at all stages of development.

We can assist your drug development program with:

  • The direct way for drug development for cognitive disorders: from laboratory research to clinical validation
  • Cognitive testing and training of raters
  • Data analysis and Interpretation

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