Alzheimer DiseaseHAPPCAP-ADNCT05256121
HAPPCAP-AD (Human-APPlication Combined Approach for Prevention of Alzheimer's Disease)
A study testing AD Risk factors balance in people with Alzheimer Disease, run by Sheba Medical Center at 1 site in Israel.
Trial summary
Currently, Alzheimer's disease (AD) has no cure putting prevention-strategies in the forefront for impeding the public health and personal consequences of this devastating disease. Read more about this study
- Who is it for?
- Ages 40 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- AD Risk factors balance
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- 4 Jun 2019to 31 Dec 2024
- 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 40 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- • Age 40-65 at enrollment to the study
- Family history of AD-All subjects recruited will have at least 1 parent diagnosed with AD (as specified below)
- All participant will be MHS (Maccabi Health System) members
- Participants must have at least two of the seven risk factors for AD (1. Smoking; 2. type 2 diabetes [T2D]; 3. Hypertension; 4. obesity/ overweight; 5. low physical inactivity; 6. low educational attainment/ mental activity; 7. depression)
- No dementia diagnosis
- Hebrew fluency
Who cannot join
- Previously diagnosed dementia•
- Any condition expected to limit the adherence to suggested intervention for 18 months
- Any significant neurologic or psychiatric disease
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Sheba Medical Center
Ramat Gan, 52621
Ithamar Ganmore, MD-PhD, ITAMARGAN@GMAIL.COM
About this study
Official title: HAPPCAP-AD (Human-APPlication Combined Approach for Prevention of Alzheimer's Disease
Currently, Alzheimer's disease (AD) has no cure putting prevention-strategies in the forefront for impeding the public health and personal consequences of this devastating disease. Seven major potentially modifiable risk factors show consistent association with AD (midlife type 2 diabetes [T2D], midlife hypertension, midlife obesity, physical inactivity, depression, smoking, and low educational attainment), with combined population-attributable risk of 30%1. A recent extensive literature review of randomized control trials on single lifestyle interventions for AD yielded negative results. The multidomain preDIVA2,3 (Prevention of Dementia by Intensive Vascular Care) and MAPT4,5 (Multidomain Alzheimer Prevention Trial) studies raised concerns regarding the multidomain approach. The multidomain lifestyle model approach of the FINGER6,7 study (Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability) brought some optimism after it presented positive results; several replication trials around the world have been launched8. However, 1) all trials focus on the elderly, 2) the impact of midlife risk factors on dementia risk is stronger than late life, and 3) the neurodegenerative changes in AD begin decades before its clinical manifestations9. A recent study showed that 2 or more cardiovascular risk factors in midlife (but not late life) predicted amyloid aggregation10.
Main goals:
To examine the feasibility and provide pilot data on effectiveness of a novel "real-life" personalized 18-months intervention for prevention of cognitive decline in middle-aged individuals (age 40-65-year-old) at high AD risk due to AD parental family history. We will implement an approach "diary-monitoring" ("Risk factors log" which will filled daily by participants, using the REDCap (Research Electronic Data Capture) software's survey) with study team guidance. We hypothesize that daily risk-factors documentation in personal "Risk factors log" will increase participant's engagement in the intervention and will enable the study team to accumulate health information, in order to improve support and counselling for improvement of risk factors. In addition to examining the feasibility of our approach, we will explore its effectiveness in both improving risk factors values, as well as improving cognitive function by comparing the HAPPCAP-AD intervention group to "control group". Last, our study will lay the foundations for a strong long-term large-scale preventive intervention in the future. We will compare this group to a partially passive control.
Read the detailed description
To examine the feasibility and provide pilot data on effectiveness of a novel "real-life" personalized 18-months intervention for prevention of cognitive decline in middle-aged individuals (age 40-65-year-old) at high AD risk due to AD parental family history. We will implement an approach "diary-monitoring" ("Risk factors log" which will filled daily by participants, using the REDCap (Research Electronic Data Capture) software's survey) with study team guidance. We hypothesize that daily risk-factors documentation in personal "Risk factors log" will increase participant's engagement in the intervention and will enable the study team to accumulate health information, in order to improve support and counselling for improvement of risk factors. In addition to examining the feasibility of our approach, we will explore its effectiveness in both improving risk factors values, as well as improving cognitive function by comparing the HAPPCAP-AD intervention group to "control group". Last, our study will lay the foundations for a strong long-term large-scale preventive intervention in the future. We will compare this group to a partially passive control.
- Conditions
- Alzheimer Disease
- Being tested
- AD Risk factors balance
- Keywords
- Alzheimer Disease; AD offspring; prevention; risk factors
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AD Risk factors balanceOther
At baseline, participants in the intervention group will be asked to fill a daily "risk-factor diaries" ("Risk factors log" using the REDCap (Research Electronic Data Capture) software's survey).
In the "Risk factors log", participants will need to answer shortly questions about their specific unbalanced risk factor.
In addition, during the 18-months intervention period, the study team will communicate with the participants by phone every 3-4 weeks to inquire about risk factors data. Before each phone call, participants' "Risk factors log" data since previous phone call will be analyzed. The team will propose alternative activities, and provide positive reinforcement and feedback.
| Study group | Role | What they receive |
|---|---|---|
| control | No intervention | At 6 months and 12months the study team will communicate with the participants by phone to inquire about risk factors data, propose alternative activities, and provide positive reinforcement and feedback |
| intervention | Experimental | At baseline, participants in the intervention group will be asked to fill a daily "risk-factor diaries" ("Risk factors log" using the REDCap (Research Electronic Data Capture) software's survey).
In the "Risk factors log", participants will need to answer shortly questions about their specific unbalanced risk factor.
In addition, during the 18-months intervention period, the study team will communicate with the participants' every 3-4 weeks by phone. Before each phone call, participants' "Risk factors log" data since previous phone call will be analyzed. The team will propose alternative activities, and provide positive reinforcement and feedback. Receives: Other: AD Risk factors balance |
What is being measured
The primary outcome is the main question the study is designed to answer.
"Risk factors log" response rate
"Risk factors log" response rate will be measured as an adherence to the intervention surrogate (response rate will be calculated as the number of submitted daily "Risk factors logs" divided by number of days in the study)
Measured: 18 months
Secondary outcomes (11)
Percent of weekly physical activity time modification in "unbalanced" participants
For participants with less than 150 minutes of weekly physical activity at baseline , percentage of relative change between weekly physical activity time (in minutes) values at baseline and 18 months (will be calculated as {([time at 18 months/ time at base line]-1)*100}.
Measured: 18 months
Percent of Body Mass Index (BMI) modification in "unbalanced" participants
For participants with BMI greater than 25 kg/m2 at baseline, percentage of relative change between BMI (BMI values at baseline and 18 months (will be calculated as {([BMI at 18 months/ BMI at base line]-1)*100}.
Measured: 18 months
Percent of number of smoked cigarettes' modification in "unbalanced" participants
For participants who smoke at baseline, percentage of relative change between number of smoked cigarettes (number of smoked cigarettes at baseline and 18 months (will be calculated as {([number of smoked cigarettes at 18 months/ number of smoked cigarettes at base line]-1)*100}.
Measured: 18 months
Percent of systolic blood pressure values modification in "unbalanced" participants
For participants with hypertension at baseline (worse than 125/85 mm Hg), percentage of relative change between systolic blood pressure (in mm Hg at baseline and 18 months (will be calculated as {([systolic blood pressure at 18 months/ systolic blood pressure at base line]-1)*100}.
Measured: 18 months
Percent of HBA1C% values modification in "unbalanced" participants
For participants with unbalanced diabetes at baseline, percentage of relative change between HBA1C% (at baseline and 18 months (will be calculated as {([HBA1C% at 18 months/ HBA1C% at base line]-1)*100}.
Measured: 18 months
Percent of depression modification in "unbalanced" participants
For participants with unbalanced depression at baseline, percentage of relative change between number of participants with depression according to their CES-D (Center for Epidemiologic Studies Depression Scale) questionnaire total score (at baseline and 18 months (will be calculated as {([CES-D total score at 18 months/ CES-D total score at base line]-1)*100}.
Measured: 18 months
Global cognitive function change
The influence of study intervention on global cognitive function will be assessed by calculating the changes in global cognitive function using a Z score between baseline and after 18 month (this is an exploratory aim since this is a pilot study).
(Global cognition z score was obtained by averaging the domains [memory, language, executive function, attention] z scores) Higher Z score represent better global cognitive function
Measured: 18 months
Change of the memory domain
The influence of study intervention on memory domain will be assessed by calculating the changes in memory function using a Z score between baseline and after 18 month (this is an exploratory aim since this is a pilot study).
Higher Z score represent better memory function
Measured: 18 months
Change of the language domain
The influence of study intervention on language domain will be assessed by calculating the changes in language function using a Z score between baseline and after 18 month (this is an exploratory aim since this is a pilot study).
Higher Z score represent better language function
Measured: 18 months
Change of the executive function domain
The influence of study intervention on executive function domain will be assessed by calculating the changes in executive function domain using a Z score between baseline and after 18 month (this is an exploratory aim since this is a pilot study).
Higher Z score represent better executive function domain function
Measured: 18 months
Change of the attention domain
The influence of study intervention on attention domain will be assessed by calculating the changes in attention domain using a Z score between baseline and after 18 month (this is an exploratory aim since this is a pilot study).
Higher Z score represent better attention function
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2022
- Study start4 Jun 2019
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Collaborators
- Maccabi Healthcare Services, Israel
- Responsible party
- Sponsor
- Investigators
- Ithamar Ganmore, MD, PhD, Principal investigator, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05256121
- Sponsor's protocol ID
- SHEBA-18-5744-IG-CTIL
- Acronym
- HAPPCAP-AD
- Status last verified
- Mar 2022
- First submitted
- 6 May 2019
- Last updated
- 24 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Participants will sign if they agree that their data will be shared anonymously with other AD/ cognition/ other studies
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HAPPCAP-AD (Human-APPlication Combined Approach for Prevention of Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT05256121
- Acronym / sponsor ID
- HAPPCAP-AD / SHEBA-18-5744-IG-CTIL
- Conditions
- Alzheimer Disease
- Keywords
- Alzheimer Disease; AD offspring; prevention; risk factors
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Collaborators
- Maccabi Healthcare Services, Israel
- Study start
- 4 Jun 2019 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 25 Feb 2022 (actual)
- 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.
Currently, Alzheimer's disease (AD) has no cure putting prevention-strategies in the forefront for impeding the public health and personal consequences of this devastating disease. Seven major potentially modifiable risk factors show consistent association with AD (midlife type 2 diabetes [T2D], midlife hypertension, midlife obesity, physical inactivity, depression, smoking, and low educational attainment), with combined population-attributable risk of 30%1. A recent extensive literature review of randomized control trials on single lifestyle interventions for AD yielded negative results. The multidomain preDIVA2,3 (Prevention of Dementia by Intensive Vascular Care) and MAPT4,5 (Multidomain Alzheimer Prevention Trial) studies raised concerns regarding the multidomain approach. The multidomain lifestyle model approach of the FINGER6,7 study (Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability) brought some optimism after it presented positive results; several replication trials around the world have been launched8. However, 1) all trials focus on the elderly, 2) the impact of midlife risk factors on dementia risk is stronger than late life, and 3) the neurodegenerative changes in AD begin decades before its clinical manifestations9. A recent study showed that 2 or more cardiovascular risk factors in midlife (but not late life) predicted amyloid aggregation10.
Main goals:
To examine the feasibility and provide pilot data on effectiveness of a novel "real-life" personalized 18-months intervention for prevention of cognitive decline in middle-aged individuals (age 40-65-year-old) at high AD risk due to AD parental family history. We will implement an approach "diary-monitoring" ("Risk factors log" which will filled daily by participants, using the REDCap (Research Electronic Data Capture) software's survey) with study team guidance. We hypothesize that daily risk-factors documentation in personal "Risk factors log" will increase participant's engagement in the intervention and will enable the study team to accumulate health information, in order to improve support and counselling for improvement of risk factors. In addition to examining the feasibility of our approach, we will explore its effectiveness in both improving risk factors values, as well as improving cognitive function by comparing the HAPPCAP-AD intervention group to "control group". Last, our study will lay the foundations for a strong long-term large-scale preventive intervention in the future. We will compare this group to a partially passive control.
Detailed description
To examine the feasibility and provide pilot data on effectiveness of a novel "real-life" personalized 18-months intervention for prevention of cognitive decline in middle-aged individuals (age 40-65-year-old) at high AD risk due to AD parental family history. We will implement an approach "diary-monitoring" ("Risk factors log" which will filled daily by participants, using the REDCap (Research Electronic Data Capture) software's survey) with study team guidance. We hypothesize that daily risk-factors documentation in personal "Risk factors log" will increase participant's engagement in the intervention and will enable the study team to accumulate health information, in order to improve support and counselling for improvement of risk factors. In addition to examining the feasibility of our approach, we will explore its effectiveness in both improving risk factors values, as well as improving cognitive function by comparing the HAPPCAP-AD intervention group to "control group". Last, our study will lay the foundations for a strong long-term large-scale preventive intervention in the future. We will compare this group to a partially passive control.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control | No intervention | –At 6 months and 12months the study team will communicate with the participants by phone to inquire about risk factors data, propose alternative activities, and provide positive reinforcement and feedback |
| intervention | Experimental | Other: AD Risk factors balanceAt baseline, participants in the intervention group will be asked to fill a daily "risk-factor diaries" ("Risk factors log" using the REDCap (Research Electronic Data Capture) software's survey). In the "Risk factors log", participants will need to answer shortly questions about their specific unbalanced risk factor. In addition, during the 18-months intervention period, the study team will communicate with the participants' every 3-4 weeks by phone. Before each phone call, participants' "Risk factors log" data since previous phone call will be analyzed. The team will propose alternative activities, and provide positive reinforcement and feedback. |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- • Age 40-65 at enrollment to the study
Key exclusion criteria (3 listed)
- Previously diagnosed dementia•
- Any condition expected to limit the adherence to suggested intervention for 18 months
- Any significant neurologic or psychiatric disease
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 |
|---|---|---|
| AD Risk factors balanceAt baseline, participants in the intervention group will be asked to fill a daily "risk-factor diaries" ("Risk factors log" using the REDCap (Research Electronic Data Capture) software's survey). In the "Risk factors log", participants will need to answer shortly questions about their specific unbalanced risk factor. In addition, during the 18-months intervention period, the study team will communicate with the participants by phone every 3-4 weeks to inquire about risk factors data. Before each phone call, participants' "Risk factors log" data since previous phone call will be analyzed. The team will propose alternative activities, and provide positive reinforcement and feedback. | Other | intervention |
Primary outcome
"Risk factors log" response rate
Time frame: 18 months
"Risk factors log" response rate will be measured as an adherence to the intervention surrogate (response rate will be calculated as the number of submitted daily "Risk factors logs" divided by number of days in the study)
11 secondary outcomes
Percent of weekly physical activity time modification in "unbalanced" participants
Time frame: 18 months
Percent of Body Mass Index (BMI) modification in "unbalanced" participants
Time frame: 18 months
Percent of number of smoked cigarettes' modification in "unbalanced" participants
Time frame: 18 months
Percent of systolic blood pressure values modification in "unbalanced" participants
Time frame: 18 months
Percent of HBA1C% values modification in "unbalanced" participants
Time frame: 18 months
Percent of depression modification in "unbalanced" participants
Time frame: 18 months
Global cognitive function change
Time frame: 18 months
Change of the memory domain
Time frame: 18 months
Change of the language domain
Time frame: 18 months
Change of the executive function domain
Time frame: 18 months
Change of the attention domain
Time frame: 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2022.
- Individual participant dataSharing planned: Yes. Participants will sign if they agree that their data will be shared anonymously with other AD/ cognition/ other studies
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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.
Ithamar Ganmore, MD, PhD principal investigator
Sheba Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AD Risk factors balance in people with Alzheimer Disease, run by Sheba Medical Center at 1 site in Israel.
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 6 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 24 May 2022. 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 Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ithamar Ganmore, MD, PhD (+972-3-5309120, itamargan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
"Risk factors log" response rate (time frame: 18 months). 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 24 May 2022.