Control and Intervention Programme on Alzheimer's Disease Risk Factors

NCT02772523 | Completed

• 1 other identifier: ALFAlife/BBRC2015
• Study Type: interventional
• Target: 409
• Locations: 1 country
• Sites: 1

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

Keywords

Primary Prevention

Outcome Measures

Primary Outcomes (3)

• Change in Short Version of the Minnesota Leisure Time Physical Activity Questionnaire

  1 year; change between baseline and one year after

• Change in 14-item mediterranean diet Questionnaire

  1 year; change between baseline and one year after

• Change in Lifestyle Activities Questionnaire (LAQ)

  1 year; change between baseline and one year after

Study Arms (1)

Intervention

OTHER

Other: Lifestyle recommendations

Interventions

Lifestyle recommendations OTHER

Dietary, and physical, cognitive and social activity recommendations

Intervention

Eligibility Criteria

• Age: 45 Years - 78 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Barcelonabeta Brain Research Center, Pasqual Maragall Foundation: lead

Study Sites (1)

Barcelonabeta Brain Research Center

Barcelona, Catalonia, 08005, Spain

Location

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2016
• First Posted: May 13, 2016
• Study Start: May 1, 2016
• Primary Completion: January 1, 2018
• Study Completion: May 1, 2019
• Last Updated: July 21, 2020

Record last verified: 2020-07

Locations

ES (1)