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

July 20, 2020 updated by: Barcelonabeta Brain Research Center, Pasqual Maragall Foundation

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

409

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Catalonia
      • Barcelona, Catalonia, Spain, 08005
        • Barcelonabeta Brain Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 78 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: Intervention
Other: Lifestyle recommendations
Dietary, and physical, cognitive and social activity recommendations

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Barcelonabeta Brain Research Center, Pasqual Maragall Foundation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 1, 2016

Primary Completion (ACTUAL)

January 1, 2018

Study Completion (ACTUAL)

May 1, 2019

Study Registration Dates

First Submitted

May 6, 2016

First Submitted That Met QC Criteria

May 11, 2016

First Posted (ESTIMATE)

May 13, 2016

Study Record Updates

Last Update Posted (ACTUAL)

July 21, 2020

Last Update Submitted That Met QC Criteria

July 20, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ALFAlife/BBRC2015

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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