Control and Intervention Programme on Alzheimer's Disease Risk Factors (ALFAlife)
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ClinicalTrials.gov Identifier: NCT02772523 |
Recruitment Status :
Completed
First Posted : May 13, 2016
Last Update Posted : July 21, 2020
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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).
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Alzheimer's Disease | Other: Lifestyle recommendations | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 409 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
Official Title: | Control and Intervention Programme on Alzheimer's Disease Risk Factors |
Actual Study Start Date : | May 2016 |
Actual Primary Completion Date : | January 2018 |
Actual Study Completion Date : | May 2019 |

Arm | Intervention/treatment |
---|---|
Intervention |
Other: Lifestyle recommendations
Dietary, and physical, cognitive and social activity recommendations |
- Change in Short Version of the Minnesota Leisure Time Physical Activity Questionnaire [ Time Frame: 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 ]
- Change in Lifestyle Activities Questionnaire (LAQ) [ Time Frame: 1 year; change between baseline and one year after ]

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Ages Eligible for Study: | 45 Years to 78 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02772523
Spain | |
Barcelonabeta Brain Research Center | |
Barcelona, Catalonia, Spain, 08005 |
Responsible Party: | Barcelonabeta Brain Research Center, Pasqual Maragall Foundation |
ClinicalTrials.gov Identifier: | NCT02772523 |
Other Study ID Numbers: |
ALFAlife/BBRC2015 |
First Posted: | May 13, 2016 Key Record Dates |
Last Update Posted: | July 21, 2020 |
Last Verified: | July 2020 |
Primary Prevention |
Alzheimer Disease Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Tauopathies Neurodegenerative Diseases Neurocognitive Disorders Mental Disorders |