Train the Brain - Cognitive and Physical Training for Slowing Dementia (TTB)

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2012 by Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy
Sponsor:
Information provided by (Responsible Party):
Eugenio Picano, National Research Council, Italy
ClinicalTrials.gov Identifier:
NCT01725178
First received: November 8, 2012
Last updated: November 12, 2012
Last verified: November 2012
  Purpose

Train The Brain is aimed at assessing the efficacy of cognitive and physical training in slowing progression to dementia in patients diagnosed with mild cognitive impairment (MCI).


Condition Intervention
Mild Cognitive Impairment
Dementia
Memory Disorders
Behavioral: Cognitive and Physical training

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Train the Brain - Effective of Cognitive and Physical Training in Slowing Progression to Dementia: a Clinical and Experimental Study

Resource links provided by NLM:


Further study details as provided by Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy:

Primary Outcome Measures:
  • Rate of cognitive decline, measured as score in neuropsychological tests [ Time Frame: 1) Baseline; 2) After seven months of intervention/control;3) Seven months after completion of intervention/control. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Modifications in brain activation during cognitive tasks, measured through functional magnetic resonance imaging [ Time Frame: Time Frame: 1) Baseline; 2) After seven months of intervention/control; 3) Seven months after completion of intervention/control. ] [ Designated as safety issue: No ]
  • Rate of loss of grey and white matter in the cortex and the hippocampus, measured through Magnetic Resonance Imaging. [ Time Frame: 1) Baseline; 2) After seven months of intervention/control; 3) Seven months after completion of intervention/control. ] [ Designated as safety issue: No ]
  • Recovery of normal frequency spectra in the electroencephalographic signal [ Time Frame: 1) Baseline; 2) After seven months of intervention/control; 3) Seven months after completion of intervention/control. ] [ Designated as safety issue: No ]
  • Improvement in vascular function and structure, as variations in Flow Mediated Dilation, carotid intima-media thickness, arterial stiffness [ Time Frame: 1) Baseline; 2) After seven months of intervention/control; 3) Seven months after completion of intervention/control. ] [ Designated as safety issue: No ]
  • Variations in brain vascular reactivity as flow and diameter response to CO2 inhalation [ Time Frame: 1) Baseline; 2) After seven months of intervention/control; 3) Seven months after completion of intervention/control. ] [ Designated as safety issue: No ]

Estimated Enrollment: 160
Study Start Date: March 2012
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Standard care
No intervention besides usual care
Active Comparator: Cognitive and physical training
Patients will undergo the comprehensive program of cognitive and physical training.
Behavioral: Cognitive and Physical training

Physical training - Three 60-minute session per week. Participants will be divided in groups of 10, supervised by physiotherapists. Physical activity combines aerobic exercises, muscle strengthening, balance improvement, joint flexibility. Once a week the session is replaced by outdoor walking; once a month by dancing.

Cognitive training - The program alternates focuses on specific functions and recreational sessions. Each session will be followed by a lesson about cognitive processes (memory, learning, attention, thought), providing tips to overcome difficulties in daily life. Sessions will focus on attention, imagination, spatial memory, categorization; memory for terms, meanings, songs, faces, names; memorization of texts; goal management.


  Show Detailed Description

  Eligibility

Ages Eligible for Study:   65 Years to 89 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age between 65 and 89
  • Successful completion of primary school
  • MCI, as Mini Mental State Examination score between 20 and 27 and confirmation through neuropsychological examination by a specialist, according to current guidelines.

Exclusion Criteria:

  • Moderate/severe dementia
  • Clinical signs of depressive disorder or other primary psychiatric disorders
  • Neoplastic diseases
  • Neurologic or musculoskeletal deficits barring neuropsychological examination or physical or cognitive training
  • Severe heart disease
  • End stage renal disease (eGFR<35 ml/min(1.73 m2)
  • Severe chronic obstructive pulmonary disease (COPD) and/or respiratory failure
  • Complicated or decompensated diabetes
  • Overt peripheral artery disease
  • Any inability to successfully complete a brain magnetic resonance scan
  • Epilepsy, drug addiction
  • Current acute diseases or recent head trauma
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01725178

Contacts
Contact: Rosa Sicari, MD, PhD +39 050 3152397 rosas@ifc.cnr.it
Contact: Nicoletta Berardi, BSc +39 050 3153164 berardi@in.cnr.it

Locations
Italy
Institute of Clinical Physiology - National Research Council Recruiting
Pisa, Italy, 56124
Contact: Rosa Sicari, MD, PhD    +39 050 3152397    rosas@ifc.cnr.it   
Principal Investigator: Rosa Sicari, MD, PhD         
Principal Investigator: Eugenio Picano, MD, PhD         
Sponsors and Collaborators
Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy
  More Information

No publications provided

Responsible Party: Eugenio Picano, MD,PhD, National Research Council, Italy
ClinicalTrials.gov Identifier: NCT01725178     History of Changes
Other Study ID Numbers: TTB-01
Study First Received: November 8, 2012
Last Updated: November 12, 2012
Health Authority: Italy: The Italian Medicines Agency

Keywords provided by Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy:
Mild Cognitive Impairment
Dementia
Memory disorders
Physical fitness

Additional relevant MeSH terms:
Memory Disorders
Dementia
Cognition Disorders
Mild Cognitive Impairment
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on August 26, 2014