Dementia: Therapeutic area expertise

Dementia clinical trials

Memory is the most essential cognitive functions of the brain. Learning, communicating and problem solving; all require an intact memory. For years the brain retains new concepts and uses stored information to solve problems. And then one day, after many years, this ability declines. Research to prevent, and delay the onset of dementia has been promising and the search for better medication is an ongoing need of the hour. It helps to understand dementia in its holistic perspective as a deterioration of the memory, intellect, as well as personality; and assess its manifestation in complete transformation of behavior, demeanor and thinking.

Onset and progress

Dementia comes to notice when small changes appear in the person’s daily routine. People with dementia ask the same question again and again and do not realize they have asked it before. They eat food and within an hour may ask for a meal again, they forget simple words and tend to substitute them with a similar sounding or wrong word; they get lost in their own street and cannot get back home once they’ve gone out. They misplace things, become distractible and moody, irritable, suspicious or even fearful. Eventually they lose drive, become passive and may refuse to go out at all.

Understanding the dementias

In dementia the nerve cells in the brain are damaged, predominantly ones that produce the memory chemical acetylcholine besides others. There are varieties of dementia in which different areas of the brain are implicated. There are features common to all these conditions with differences depending on the area of brain involved. Some deteriorate rapidly while others progressively worsen over the years.

Clinical trial protocols

Trials in dementia call for additional sensitivity and attention. Old age comes with a gamut of physical ailments. Informed consent in those with diminishing cognitive capacity is challenge in itself. Senior citizens have deep cultural connections and incorporating these in protocols is also essential. MINDFRAMES team holds experience in medical review of international drug trial documents in dementia research. Training in the geriatric therapeutic area is an asset to study sponsors and assists smooth formulation and conduction of the study.

Understanding dementias

Prototypal knowledge of dementias:

  • Immense symptom heterogeneity
  • Awareness of pseudo-dementia
  • Progressive or rapid deterioration
  • Neurotransmitter imbalances
  • Symptom variation in varieties
  • Attaining/ maintaining remission

Dementia training

The MINDFRAMES therapeutic area expertise in dementias and extensive past experience with international dementia trials have encompassed detailed explanation of core illness characteristics.

  • Knowing the different dementias
  • Knowing memory assessment
  • Clinical symptom presentation
  • Diagnostic criteria DSM and ICD
  • Different assessment tools
  • Diagnostic interview process
  • Rating scales in all dementias
  • Source documentation and history
  • Progress report and prognosis
  • Site monitoring tools and tips
  • Anticipated adverse events
  • Expected realistic outcomes
  • Understanding trial dropouts
  • Communicating with investigators