{
  "FullStudy":{
    "Rank":218060,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01513252",
          "OrgStudyIdInfo":{
            "OrgStudyId":"RC31/11/231"
          },
          "SecondaryIdInfoList":{
            "SecondaryIdInfo":[
              {
                "SecondaryId":"2011-A00764-37",
                "SecondaryIdType":"Other Identifier",
                "SecondaryIdDomain":"ID-RCB"
              }
            ]
          },
          "Organization":{
            "OrgFullName":"University Hospital, Toulouse",
            "OrgClass":"OTHER"
          },
          "BriefTitle":"Long-term Effects of Interventional Strategies to Prevent Cognitive Decline in Elderly.",
          "OfficialTitle":"A 2-years Extension Study of MAPT Trial : Evaluation of the Long Term Effects of Interventional Strategies to Prevent the Decline in Cognitive Functioning in Frail Older Adults",
          "Acronym":"MAPT-PLUS"
        },
        "StatusModule":{
          "StatusVerifiedDate":"May 2018",
          "OverallStatus":"Recruiting",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"December 2011"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"December 2018",
            "PrimaryCompletionDateType":"Anticipated"
          },
          "CompletionDateStruct":{
            "CompletionDate":"December 2018",
            "CompletionDateType":"Anticipated"
          },
          "StudyFirstSubmitDate":"December 30, 2011",
          "StudyFirstSubmitQCDate":"January 16, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 20, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"May 30, 2018",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"May 31, 2018",
            "LastUpdatePostDateType":"Actual"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Sponsor"
          },
          "LeadSponsor":{
            "LeadSponsorName":"University Hospital, Toulouse",
            "LeadSponsorClass":"OTHER"
          }
        },
        "OversightModule":{
          "OversightHasDMC":"Yes"
        },
        "DescriptionModule":{
          "BriefSummary":"The MAPT PLUS study is a two-year extension of follow-up of the patients included in the MAPT preventive study, after completion of the interventions. Subjects in the four groups of the MAPT study will be prospectively followed. MAPT is a multicentre, randomised, placebo-controlled study, using a 4-group design with 3 treatment groups (omega 3 alone, multi-domain intervention alone, omega 3 plus multi-domain intervention, n=420 each) and a placebo group (n=420). The MAPT PLUS study will be an extension of the MAPT study and includes an annual follow-up for two years.",
          "DetailedDescription":"The MAPT PLUS study is a follow-up of subjects initially included in an interventional study. The follow-up that we propose in this request for funding does not involve any intervention, but aims to assess the long-term effect of the interventions previously carried out during the three years of the MAPT study.\n\n* Description of the interventions to which subjects are exposed during the first 3 years of follow-up (MAPT study) :\n\nIn the MAPT study, subjects are randomized into 4 groups:\n\nV0137 CA group: 2 soft capsules of V0137 CA once a day (2 x 400 mg/day);\nMulti-domain intervention group (nutrition, physical activity, cognitive stimulation, social activities) + placebo, 2 soft capsules once a day ;\nMulti-domain intervention group (nutrition, physical activity, cognitive stimulation, social activities) + V0137 CA, 2 soft capsules once a day ;\nPlacebo group: 2 soft capsules of placebo once a day. * Description of the multidomain intervention : The multi-domain intervention consists of collective training sessions and a yearly personalized preventive consultation which aims to detect risk factors (sensory disturbances, difficulty in walking, nutritional disturbances, vascular risk factors) and to set up management in collaboration with the general practitioner.\n\nThe collective sessions take place in groups of 6 to 8 subjects. In the first month, two sessions a week are scheduled, and in the second month, one session a week. The first two months correspond to the intensive programme. Each session comprises 1 hour of cognitive training, 45 minutes of information on physical activity and 15 minutes of dietary advice. From the third month, sessions are held monthly and aim to consolidate the key messages and to stimulate adherence to the programme. The sessions are shorter (1 hour review of one of the domains of the intensive programme). \" Booster \" sessions (2 hours) are delivered at 12 and 24 months after the first sessions of the intensive programme. Twenty-minute individual interviews also take place every 6 months with the leader of the training sessions (6 interviews in the course of 3 years)."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Frail Elderly"
            ]
          },
          "KeywordList":{
            "Keyword":[
              "Cognitive decline",
              "prevention",
              "omega-3 fatty acids",
              "nutrition exercise",
              "cognitive training",
              "social activities",
              "frailty"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Interventional",
          "PhaseList":{
            "Phase":[
              "Not Applicable"
            ]
          },
          "DesignInfo":{
            "DesignInterventionModel":"Single Group Assignment",
            "DesignPrimaryPurpose":"Prevention",
            "DesignMaskingInfo":{
              "DesignMasking":"None (Open Label)"
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"1150",
            "EnrollmentType":"Anticipated"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"1",
                "ArmGroupType":"Experimental",
                "ArmGroupDescription":"Gröber and Buschke test",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Behavioral: Gröber and Buschke test"
                  ]
                }
              }
            ]
          },
          "InterventionList":{
            "Intervention":[
              {
                "InterventionType":"Behavioral",
                "InterventionName":"Gröber and Buschke test",
                "InterventionDescription":"spontaneous delayed recall score after a 5 years follow-up",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "1"
                  ]
                }
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"Gröber and Buschke test (spontaneous delayed recall score)",
                "PrimaryOutcomeDescription":"Assessment of cognitive and functional performances according to the spontaneous delayed recall score(Gröber and Buschke test)",
                "PrimaryOutcomeTimeFrame":"2 years"
              },{
                "PrimaryOutcomeMeasure":"Cognitive and functional performance (Gröber and Buschke test-spontaneous delayed recall score)",
                "PrimaryOutcomeDescription":"Assessment of cognitive and functional performances by using the Gröber and Buschke test (spontaneous delayed recall score)at 5 years after the participation to the MAPT study.",
                "PrimaryOutcomeTimeFrame":"2 years"
              }
            ]
          },
          "SecondaryOutcomeList":{
            "SecondaryOutcome":[
              {
                "SecondaryOutcomeMeasure":"MRI test",
                "SecondaryOutcomeDescription":"Evaluation of the long-term impact of MAPT study interventions on changes in markers of cerebral atrophy (overall brain volume of specific brain structures such as the hippocampus)",
                "SecondaryOutcomeTimeFrame":"2 years"
              },{
                "SecondaryOutcomeMeasure":"Cost-effectiveness Evaluation",
                "SecondaryOutcomeDescription":"Evaluation of the long-term impact of the MAPT interventions in terms of cost-effectiveness ratio by using a medico-economic data collection",
                "SecondaryOutcomeTimeFrame":"2 years"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nSubjects who meet the following criteria will be included in the MAPT PLUS study :\n\nfrail elderly subjects participating in the MAPT study and still followed at 3 years,\nsubjects capable of understanding the protocol, complying with its requirements and attending the follow-up visits proposed as part of the extended phase of the MAPT study,\nsubjects capable of giving their written informed consent and complying with the requirements of the study,\nsubjects covered by a health insurance system.\n\nExclusion Criteria:\n\nSubjects who fulfill at least one of the following criteria will not be included in the MAPT PLUS study :\n\nknown presence of dementia or Alzheimer's disease (DSM IV criteria) diagnosed during the MAPT follow-up,\nknown presence of severe diseases that are life-threatening in the short term,\nvisual or hearing impairments that are incompatible with performance and/or interpretation of the neuropsychological tests,\nhistory and/or presence of any disorder (severe depression or generalized anxiety) which, according to the investigator, is likely to interfere with the results of the study or to expose the subject to a supplementary risk,\nparticipation in another clinical study during the period of the present study,\nsubjects who have refused cognitive evaluation during the MAPT follow-up,\nsubjects deprived of their freedom by administrative or judicial decision, or under guardianship,\nwith regard to performance of MRI: presence of a pacemaker or metallic materials, claustrophobia.",
          "HealthyVolunteers":"Accepts Healthy Volunteers",
          "Gender":"All",
          "MinimumAge":"70 Years",
          "StdAgeList":{
            "StdAge":[
              "Older Adult"
            ]
          }
        },
        "ContactsLocationsModule":{
          "OverallOfficialList":{
            "OverallOfficial":[
              {
                "OverallOfficialName":"Bruno Vellas, MD",
                "OverallOfficialAffiliation":"University Hospital, Toulouse",
                "OverallOfficialRole":"Principal Investigator"
              }
            ]
          },
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"UH Toulouse - La Grave",
                "LocationStatus":"Recruiting",
                "LocationCity":"Toulouse",
                "LocationZip":"31059",
                "LocationCountry":"France",
                "LocationContactList":{
                  "LocationContact":[
                    {
                      "LocationContactName":"Bruno VELLAS, PR",
                      "LocationContactRole":"Contact",
                      "LocationContactPhone":"33 5 61 77 64 25",
                      "LocationContactEMail":"vellas.b@chu-toulouse.fr"
                    },{
                      "LocationContactName":"Sophie GILLETTE, PHD",
                      "LocationContactRole":"Contact",
                      "LocationContactPhone":"33 5 61 77 64 05",
                      "LocationContactEMail":"gillette.s@chu-toulouse.fr"
                    }
                  ]
                }
              }
            ]
          }
        },
        "ReferencesModule":{
          "ReferenceList":{
            "Reference":[
              {
                "ReferencePMID":"31558366",
                "ReferenceType":"derived",
                "ReferenceCitation":"Delrieu J, Payoux P, Carrié I, Cantet C, Weiner M, Vellas B, Andrieu S. Multidomain intervention and/or omega-3 in nondemented elderly subjects according to amyloid status. Alzheimers Dement. 2019 Nov;15(11):1392-1401. doi: 10.1016/j.jalz.2019.07.008. Epub 2019 Sep 23."
              },{
                "ReferencePMID":"30498824",
                "ReferenceType":"derived",
                "ReferenceCitation":"Pothier K, de Souto Barreto P, Maltais M, Rolland Y, Vellas B. Shifting from Declines to Improvements: Associations between a Meaningful Walking Speed Change and Cognitive Evolution over Three Years in Older Adults. J Nutr Health Aging. 2018;22(10):1183-1188. doi: 10.1007/s12603-018-1059-8."
              },{
                "ReferencePMID":"30207586",
                "ReferenceType":"derived",
                "ReferenceCitation":"Lilamand M, Cesari M, Cantet C, Payoux P, Andrieu S, Vellas B; the MAPT/DSA study group. Relationship Between Brain Amyloid Deposition and Instrumental Activities of Daily Living in Older Adults: A Longitudinal Study from the Multidomain Alzheimer Prevention Trial. J Am Geriatr Soc. 2018 Oct;66(10):1940-1947. doi: 10.1111/jgs.15497. Epub 2018 Sep 12."
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        },
        "ConditionBrowseModule":{
          "ConditionMeshList":{
            "ConditionMesh":[
              {
                "ConditionMeshId":"D000060825",
                "ConditionMeshTerm":"Cognitive Dysfunction"
              }
            ]
          },
          "ConditionAncestorList":{
            "ConditionAncestor":[
              {
                "ConditionAncestorId":"D000003072",
                "ConditionAncestorTerm":"Cognition Disorders"
              },{
                "ConditionAncestorId":"D000019965",
                "ConditionAncestorTerm":"Neurocognitive Disorders"
              },{
                "ConditionAncestorId":"D000001523",
                "ConditionAncestorTerm":"Mental Disorders"
              }
            ]
          },
          "ConditionBrowseLeafList":{
            "ConditionBrowseLeaf":[
              {
                "ConditionBrowseLeafId":"M28292",
                "ConditionBrowseLeafName":"Cognitive Dysfunction",
                "ConditionBrowseLeafAsFound":"Cognitive Decline",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M1175",
                "ConditionBrowseLeafName":"Frailty",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M4884",
                "ConditionBrowseLeafName":"Cognition Disorders",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M20420",
                "ConditionBrowseLeafName":"Neurocognitive Disorders",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M3396",
                "ConditionBrowseLeafName":"Mental Disorders",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M13056",
                "ConditionBrowseLeafName":"Psychotic Disorders",
                "ConditionBrowseLeafRelevance":"low"
              }
            ]
          },
          "ConditionBrowseBranchList":{
            "ConditionBrowseBranch":[
              {
                "ConditionBrowseBranchAbbrev":"BXM",
                "ConditionBrowseBranchName":"Behaviors and Mental Disorders"
              },{
                "ConditionBrowseBranchAbbrev":"All",
                "ConditionBrowseBranchName":"All Conditions"
              },{
                "ConditionBrowseBranchAbbrev":"BC23",
                "ConditionBrowseBranchName":"Symptoms and General Pathology"
              }
            ]
          }
        }
      }
    }
  }
}