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Completed

NCT Number: NCT02772523

Control and Intervention Programme on Alzheimer's Disease Risk Factors

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).

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Key information

Age range

45 year–78 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Barcelonabeta Brain Research Center

Barcelona, Catalonia, 08005, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lifestyle Recommendations

Other

Dietary, and physical, cognitive and social activity recommendations

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Barcelonabeta Brain Research Center, Pasqual Maragall Foundation

Other

Registry information

Acronym: ALFAlife

Important dates

Study start
2016
Primary completion
2018
Study completion
2019
First posted
May 13, 2016
Registry last updated
Jul 21, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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