Control and Intervention Programme on Alzheimer's Disease Risk Factors

NCT ID: NCT02772523

Last Updated: 2020-07-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 409 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-05-31
• Study Completion Date: 2019-05-31

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).

Conditions

Alzheimer's Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Intervention

Group Type: OTHER

Lifestyle recommendations

Intervention Type: OTHER

Dietary, and physical, cognitive and social activity recommendations

Interventions

Lifestyle recommendations

Dietary, and physical, cognitive and social activity recommendations

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 78 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Barcelonabeta Brain Research Center, Pasqual Maragall Foundation

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Barcelonabeta Brain Research Center

Barcelona, Catalonia, Spain

Countries

Spain

Other Identifiers

ALFAlife/BBRC2015

Identifier Type: -

Identifier Source: org_study_id