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Control and Intervention Programme on Alzheimer's Disease Risk Factors (ALFAlife)

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ClinicalTrials.gov Identifier: NCT02772523
Recruitment Status : Completed
First Posted : May 13, 2016
Last Update Posted : July 21, 2020
Sponsor:
Information provided by (Responsible Party):
Barcelonabeta Brain Research Center, Pasqual Maragall Foundation

Study Description
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Brief Summary:

Recent epidemiologic studies are identifying a number of modifiable risk and protective factors that may influence in the incidence of Alzheimer's disease (AD). Therefore, the combination of an early detection of individuals at risk together with interventional studies targeted to the control of modifiable risk factors makes primary prevention programmes to become a new and real therapeutic strategy.

In this scenario, the investigators have designed the ALFAlife study, a programme of control and intervention on the modifiable AD risk factors. Throughout this study, participants will be given a number of healthy lifestyle guidelines that are personalised depending on their specific risk profile. These guidelines refer to smoking and dietary habits and physical, cognitive and social activity. The investigators hypothesis is that the follow-up of these guidelines will favor a change of participants' lifestyle habits towards healthier ones. In addition, the investigators hypothesise that changes in these lifestyle habits will have an effect on objective physiological measures (such as blood pressure and cholesterol levels).


Condition or disease Intervention/treatment Phase
Alzheimer's Disease Other: Lifestyle recommendations Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 409 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Control and Intervention Programme on Alzheimer's Disease Risk Factors
Actual Study Start Date : May 2016
Actual Primary Completion Date : January 2018
Actual Study Completion Date : May 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Intervention Other: Lifestyle recommendations
Dietary, and physical, cognitive and social activity recommendations


Outcome Measures
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Primary Outcome Measures :
  1. Change in Short Version of the Minnesota Leisure Time Physical Activity Questionnaire [ Time Frame: 1 year; change between baseline and one year after ]
  2. Change in 14-item mediterranean diet Questionnaire [ Time Frame: 1 year; change between baseline and one year after ]
  3. Change in Lifestyle Activities Questionnaire (LAQ) [ Time Frame: 1 year; change between baseline and one year after ]

Eligibility Criteria
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Ages Eligible for Study:   45 Years to 78 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Participants in the ALFA study (NCT01835717)
  • Computer literacy
  • Accept study's tests and procedures
  • Signature of informed consent

Exclusion Criteria:

  • Cognitive impairment assessed by clinical criteria that, according to the investigator's evaluation could interfere with the study's follow-up.
  • Anxiety or depression assessed by clinical criteria that, according to the investigator's evaluation could interfere with the study's follow-up.
  • Visual and/or hearing impairment severe enough to impede tests realization.
  • Major psychiatric or neurological disorder or other diseases that according to the investigator's evaluation could interfere with the study's follow-up.
  • Antecedents of infarction, ischemic heart disease, stroke, peripheral vascular disease, stent or aneurysm clip
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02772523


Locations
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Spain
Barcelonabeta Brain Research Center
Barcelona, Catalonia, Spain, 08005
Sponsors and Collaborators
Barcelonabeta Brain Research Center, Pasqual Maragall Foundation
More Information
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Responsible Party: Barcelonabeta Brain Research Center, Pasqual Maragall Foundation
ClinicalTrials.gov Identifier: NCT02772523    
Other Study ID Numbers: ALFAlife/BBRC2015
First Posted: May 13, 2016    Key Record Dates
Last Update Posted: July 21, 2020
Last Verified: July 2020
Keywords provided by Barcelonabeta Brain Research Center, Pasqual Maragall Foundation:
Primary Prevention
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders