Control and Intervention Programme on Alzheimer's Disease Risk Factors

Alzheimer's Disease Clinical Trial

— ALFAlife  

Official title:

Control and Intervention Programme on Alzheimer's Disease Risk Factors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02772523
• Other study ID #: ALFAlife/BBRC2015
• Status: Completed
• Phase: N/A
• Start date: May 2016
• Est. completion date: May 2019

Study information

• Verified date: July 2020
• Source: Barcelonabeta Brain Research Center, Pasqual Maragall Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 409
• Est. completion date: May 2019
• Est. primary completion date: January 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years to 78 Years

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Other:
• Lifestyle recommendations
Dietary, and physical, cognitive and social activity recommendations

Locations

Country	Name	City	State
Spain	Barcelonabeta Brain Research Center	Barcelona	Catalonia

Sponsors (1)

Lead Sponsor	Collaborator
Barcelonabeta Brain Research Center, Pasqual Maragall Foundation

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Short Version of the Minnesota Leisure Time Physical Activity Questionnaire		1 year; change between baseline and one year after
Primary	Change in 14-item mediterranean diet Questionnaire		1 year; change between baseline and one year after
Primary	Change in Lifestyle Activities Questionnaire (LAQ)		1 year; change between baseline and one year after