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Clinical Trials

Date: 2015-11-09

Type of information: Initiation of the trial

phase:

Announcement: initiation of the trial

Company: Teva Pharmaceutical Industries (Israel) University College London (UK)

Product:

Action mechanism:

Disease: Alzheimer's disease

Therapeutic area: Neurodegenerative diseases

Country: UK

Trial details:

The Pilot Longitudinal Study in Alzheimer's Disease of Central Markers of Microglial Activation (PADMMA) study is a two-year study in 20 patients that will assess the prevalence and pattern of CNS microglial activation in individuals with prodromal AD with Mild Cognitive Impairment (MCI) or mild AD through the use of PET imaging and comparison with CSF and peripheral markers of inflammation..
The total study duration will be 2 years, with 1 year for the recruitment period. The study duration for each participant is 12 months. It will be run between the DRC and the LWENC CRF at the UCL Institute of Neurology (IoN) and the UCLH National Hospital for Neurology and Neurosurgery (NHNN). Dr Cath Mummery is Consultant Neurologist and Clinical Lead at the DRC's Cognitive Disorders Clinic University College London Hospital (UCLH), and is supported by the NIHR Queen Square Biomedical Research Unit (BRU) and NIHR UCLH BRC ( Biomedical Research Centre ). Dr Vincenzo Libri is Consultant Clinical Pharmacologist and Head of the LWENC.
Participants will only be recruited at a single site - University College London Hospital (UCLH) and will come from the Dementia Research Centre cognitive disorder clinics, from the National Institute of Health Research (NIHR) clinical research network (CRN) and from the UK Dementia Registry, and JDR ( Join Dementia Research ).

Latest news:

* On November 19, 2015, Teva Pharmaceutical Industries and University College London (UCL) announced the start of a unique study, combining state-of-the-art brain imaging with key biomarkers, aimed at building a better understanding of the role of inflammation in neurodegenerative disease and potentially a new approach in its early diagnosis and treatment.
The Pilot Longitudinal Study in Alzheimer's Disease of Central Markers of Microglial Activation (PADMMA) study is a two-year study in 20 patients that will assess, using PET imaging, the prevalence and pattern of activation of a specific type of cell, called microglia, in the central nervous system (CNS) in people with certain symptoms of neurodegenerative disease. It is key demonstration of Teva's commitment towards dementia research made following the UK Government's Dementia Summit, spearheaded by UK Prime Minister David Cameron .
The role of inflammation is key in the field of neurodegeneration. It is implicated in the neuronal dysfunction that is the result of some of the most devastating neurodegenerative diseases. Microglia play a central role in neuro-inflammation, and defining reliable biomarkers of microglial activation, and their changes over time, will provide us with crucial information for developing treatment trials with neuro-inflammation as a novel therapeutic target.
The study will be performed at the University College London (UCL) Dementia Research Centre (DRC) for which Dr Mummery is Clinical Trials lead, and the Leonard Wolfson Experimental Neurology Centre (LWENC) Clinical Research Facility (CRF), headed by Dr Vincenzo Libri , who is also Co-Investigator of the PADMMA study. Imaging will be undertaken by Imanova, at the Centre for Imaging Sciences , Imperial College London.
This unique study is the result of an extensive collaborative effort supported by the UK Israel Tech Hub at the British Embassy in Israel - helping Teva, UCL and Imanova, come together in an effort to change the paradigm in neurodegenerative disease.

Is general: Yes