Tomislav Babic (Austria)
Worldwide Clinical Trials
Scientific solutions
Tomislav Babić, MD, PhD is a Vice President, Neuroscience Franchise, Worldwide Clinical Trials Inc. Dr. Babić is responsible for the scientific and medical leadership of neurology clinical research initiatives undertaken in the international arena. His responsibilities encompass aspects of hypothesis generation and testing, and include protocol/strategic program design and development, as well as assistance in the analysis and clinical interpretation or results for all phases of clinical development. Prior to join Worldwide Clinical Trials he was a therapeutic leader in inVentiv Health Clinical neurology medical and scientific affairs, when he has created several protocols for randomized controlled trials in population with early and advanced Parkinson’s disease, Alzheimer’s disease, multiple sclerosis and neuropathies. He has designed a few program development plans in advanced Parkinson’s disease, multiple sclerosis and Alzheimer’s disease and provided consultancy service. He was a member of two advisory boards in Parkinson’s disease programs. In summary he was Therapeutic area leader in more than 200 studies phase II and III in neurodegeneretive disorders. Dr. Babić was principal investigator in more than 60 phase II and III clinical trials in neurodegenerative disorders, epilepsy and stroke. He was also a member of a substantial number of program development boards providing neurological and neuropharmacological input for several CNS indications. He is board certified neurologist, with MA degree in Clinical pharmacology. He is author of more than 70 peer reviewed articles and books in neurodegenerative disorders.

Presenter of 2 Presentations

 Conference Calendar

Discussants

Session Name
0430 - FORUM ON:BLOOD-BASED BIOMARKERS COMPARISON TO FLUID-BASED BIOMARKERS, IMAGING, AND ASSESSMENT OF DIAGNOSTIC & TREATMENT EFFECTS TREATMENT EFFECT: HOW TO MEASURE MINIMAL CLINICAL EFFICACY? (ID 20)
Session Type
FORUM
Date
Wed, 16.03.2022
Session Time
06:30 PM - 07:30 PM
Room
ONSITE PLENARY: 115-117
Lecture Time
06:30 PM - 07:30 PM
Presenter

PRE-RECORDED: OVERCOMING CHALLENGES OF DRUG DEVELOPMENT IN DEMENTIA WITH LEWY BODY

Session Name
1540 - AD, LBD DIAGNOSIS, IMAGING & CLINICAL TRIALS (ID 79)
Session Type
SYMPOSIUM
Date
Sat, 19.03.2022
Session Time
09:10 AM - 11:10 AM
Room
ONSITE: 113
Lecture Time
10:40 AM - 10:55 AM
Presenter

Abstract

Aims

Dementia with Lewy bodies (DLB) is a progressive neurodegenerative
disorder characterized by intracellular neuronal accumulation of pathological alpha-synuclein clusters. DLB has been considered as the second most common type of dementia associated with more rapid decline than Alzheimer’s dementia.
To provide a systematic review of subject selection criteria and outcome measures in Randomized Placebo Controlled Clinical Trials (RPCCT) of pharmacological interventions in the DLB.

Methods

We systematically searched the electronical PubMed database for reports of RPCCT published as a full text in English since 2000 till December 2021. Key words used were: DLB; randomized, placebo, clinical trials.

Results

A total of 13 RPCTs have been identified. Twelve studies assessed pharmacological interventions, whereas one examined transcranial direct current stimulation (tDCS). The 13 reviewed studies included a total of 2481 individuals. All studies have used Consensus diagnostic criteria for diagnosis of DLB and MMSE as entry criteria. Seven studies included subjects with Parkinson’s disease dementia (PDD). The sample size ranged from 34 to 541 participants (median 142). Durations of the studies ranged from 4 to 26 weeks (median = 12).

Conclusions

A review of effect sizes suggested some evidence that assessment of motor functions using Unified Parkinson’s Disease Rating Scale (UPDRS), and behavioral symptoms using neuropsychiatric inventory (NPI) may be sensitive to changes associated with treatment. However, no intervention showed overall treatment effects. The large variability among outcome measures rendered a meta-analytic review implausible and there remains a need for standardized criteria and assessments in order to assesses potential disease treatment.
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