Cognition and (epi)genetics in memory clinic patients with Mild Cognitive Impairment and Subjective Cognitive Decline: a longitudinal behavior-genomics study - Cognition and (epi)genetics in MCI and SCD

Takeda0 个研究点目标入组 144 人开始时间: 待定最近更新: 2024年4月23日

适应症

试验速览

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•MCI patients
•1) Referred to the memory clinic for the evaluation of cognitive problems, and
•2) Patients have to fulfil the new DSM-V criteria for mild neurocognitive disorder (NCD):
•a) Evidence of modest cognitive decline from a previous level of performance in one or more cognitive domains, being between 1-2 standard deviations (SD) below average. The evidence should consist of concern of the individual, a knowledgeable informant, or the clinician that there's been a mild decline in cognitive functioning; and a modest impairment in cognitive performance, documented by standardized neuropsychological testing.
•b) The cognitive deficits do not interfere with capacity for independence in everyday activities.
•c) The cognitive deficits don't occur exclusively in context of delirium, and are not better explained by another mental disorder.
•These inclusion criteria, and collection of clinical data, will allow use of different internationally used MCI criteria.;SCD patients (based on Jessen et al., Alz Dem, 2014)
•1) Also being referred for the evaluation of cognitive complaints;
•2) Self-experienced persistent decline in cognitive capacity in comparison with a previously normal status and unrelated to an acute event; and
•3) Normal age-, gender-, and education- adjusted performance on standardized cognitive tests.
•SCD might be a very early symptom of neurodegenerative brain processes, and are therefore interesting for evaluation in the present study.

•Exclusion criteria for both groups of patients are: having received chemo treatment in the past year, Normal Pressure Hydrocephalus, Morbus Huntington, Parkinson's Disease, recent Transient Ischemic Attack (TIA) or Cerebrovascular Accident (CVA) (< 2 years), TIA/CVA followed by cognitive decline (within three months), history of schizophrenia, bipolar disorder or psychotic symptoms not otherwise specified or previous treatment for these diseases (ever), current major depressive disorder, cognitive problems due to alcohol abuse, brain tumor, epilepsy, encephalitis, mental incompetence for deciding participation (also when patient develop mental incompetence during the study, they will be excluded for follow-up assessments), or patients with the expectation that a follow-up assessment after one year will not be possible. During the period of the present study, patients are not allowed to participate in other drug trials; other treatments or interventions are no exclusion criteria.

发起方

Takeda