Alzheimer's DiseaseALFAlifeNCT02772523
Control and Intervention Programme on Alzheimer's Disease Risk Factors
A study testing Lifestyle recommendations in people with Alzheimer's Disease, run by Barcelonabeta Brain Research Center, Pasqual Maragall Foundation at 1 site in Spain.
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… Read more about this study
- Who is it for?
- Ages 45 to 78 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- Lifestyle recommendations
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 409 participants
- Where
- 1 siteSpain
- Study dates
- May 2016to May 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 78 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants in the ALFA study (NCT01835717)
- Computer literacy
- Accept study's tests and procedures
- Signature of informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Lifestyle recommendations
- Keywords
- Primary Prevention
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle recommendationsOther
Dietary, and physical, cognitive and social activity recommendations
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Other | Not described Receives: Other: Lifestyle recommendations |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Short Version of the Minnesota Leisure Time Physical Activity Questionnaire
Measured: 1 year; change between baseline and one year after
Change in 14-item mediterranean diet Questionnaire
Measured: 1 year; change between baseline and one year after
Change in Lifestyle Activities Questionnaire (LAQ)
Measured: 1 year; change between baseline and one year after
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2016 (estimated)
- Study startMay 2016
- Primary completionJan 2018
- Study completionMay 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 409 participants (actual)
Sponsor and investigators
- Lead sponsor
- Barcelonabeta Brain Research Center, Pasqual Maragall Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02772523
- Sponsor's protocol ID
- ALFAlife/BBRC2015
- Acronym
- ALFAlife
- Status last verified
- Jul 2020
- First submitted
- 6 May 2016
- Last updated
- 21 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Control and Intervention Programme on Alzheimer's Disease Risk Factors
- ClinicalTrials.gov ID
- NCT02772523
- Acronym / sponsor ID
- ALFAlife / ALFAlife/BBRC2015
- Conditions
- Alzheimer's Disease
- Keywords
- Primary Prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 409 participants (actual)
- Lead sponsor
- Barcelonabeta Brain Research Center, Pasqual Maragall FoundationUniversity, hospital or other
- Study start
- May 2016 (actual)
- Primary completion
- Jan 2018 (actual)
- Study completion
- May 2019 (actual)
- First posted
- 13 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Other | Other: Lifestyle recommendations |
Who may qualify
- Ages
- 45 to 78 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participants in the ALFA study (NCT01835717)
- Computer literacy
- Accept study's tests and procedures
- Signature of informed consent
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lifestyle recommendationsDietary, and physical, cognitive and social activity recommendations | Other | Intervention |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lifestyle recommendations in people with Alzheimer's Disease, run by Barcelonabeta Brain Research Center, Pasqual Maragall Foundation at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Short Version of the Minnesota Leisure Time Physical Activity Questionnaire (time frame: 1 year; change between baseline and one year after). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2020.