Clinical trial NCT02114580: Brain Plasticity Following Aerobic Exercise in Patient With Mild Cognitive Impairment: Neuroimaging Study
Official title: Brain Plasticity Following Aerobic Exercise in Patient With Mild Cognitive Impairment: Neuroimaging Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Mild Cognitive Impairment
Keywords: mild cognitive impairment
exercise
brain plasticity
FMRI
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
First posted: 2014-04-15
Enrollment: 40
Sex: ALL
Minimum age (years): 60
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The proposed study aims to explore brain mechanisms mediating the cognitive benefits of aerobic exercise in patients with mild cognitive impairment- a prodromal stage of Alzheimer disease. We will perform FMRI experiments, as well as laboratory and behavioral tests that will advance our knowledge about the nature of these mechanisms. Participants will participate in individual- tailored aerobic training program. Pre and post evaluation will identify brain changes following the training using advanced techniques of brain imaging. Cognitive performance will be assessed prior and at the end of the program, as well as endocrine markers reflecting improvement in learning abilities. Moreover, demonstrating cortical plasticity in subjects with aMCI has tremendous practical significance for these subjects .

Detailed description: Mild cognitive impairment (MCI), a prodromal stage of Alzheimer disease (AD), refers to a transitional state between the cognition of normal aging and dementia such AD. To date, therapeutic approaches to AD are symptomatic and of modest efficacy. Nontheless, recent studies in animal models or healthy subjects, have shown that aerobic exercise affect brain plasticity. The current proposal aims at exploring the brain mechanisms mediating the cognitive benefits of aerobic exercise in patients with amnestic MCI (aMCI),in compare to a control group of subjects with aMCI receiving stretching exercise. More specifically, we aim to perform two fMRI experiments, that will advance our knowledge about the nature of mechanism of the cognitive benefit resulting of aerobic exercise. Our preleminary results suggest that subjects with aMCI show different hierarchy of reliable responses when processing long time scales in auditory task. Therefore, in the first experiment, we will evaluate how these patterns of temporal hierarchy of language processing are affected by aerobic exercise. Next, we will explore whether aerobic exercise affect memory enocoding task, which rely on areas in the medial temporal lobe who bear a heavy neuropathological burden in MCI. The insights gained from the study may have important clinical implications for patients who are at the early stages of Alzheimer's disease

Eligibility criteria: Inclusion Criteria:

* Only patients at the age of 60-90 who have met criteria for a diagnosis of MCI will be included.
* Participants will be both men and women, and this factor is not specifically addressed.

Exclusion Criteria:

* Patients with any significant medical (i.e. cardiac), neurological (other than MCI) illness will be excluded from the study.
* Medical and neurological illnesses will be ruled out by physical and neurological examinations, reports of the patients' treating physicians and medical records.
* The experiments will be undertaken in compliance with the safety guidelines for MRI research. Based on initial fMRI screening questionnaires, subjects will be excluded if they indicate any risk factor on these questionnaires.

Primary outcomes:
measure: functional Magnetic Resonance Imaging
timeFrame: two weeks prior to intervention
Secondary outcomes:
measure: Neuropsychological assessment
timeFrame: two weeks prior to intervention
Other outcomes:
measure: Cardiorespiratory fitness assessment, Serum concentration of BDNF
timeFrame: two weeks prior to intervention
Locations:
city: Tel-Aviv
country: Israel
facility: Tel-Aviv Sourasky Medical Center
Study officials:
affiliation: Functional Brain Center, Wohl Institute for Advanced Imaging, Tel-Aviv Sourasky Medical Center, Tel-Aviv, Israel
name: Yulia Lerner, PhD
role: PRINCIPAL_INVESTIGATOR
References: