HAPPCAP-AD (Human-APPlication Combined Approach for Prevention of Alzheimer's Disease)

NCT05256121 | Unknown

• 1 other identifier: SHEBA-18-5744-IG-CTIL
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Alzheimer Disease

Keywords

Alzheimer Disease; AD offspring; prevention; risk factors

Outcome Measures

Primary Outcomes (1)

• "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)

  18 months

Secondary Outcomes (11)

• Percent of weekly physical activity time modification in "unbalanced" participants

  18 months

• Percent of Body Mass Index (BMI) modification in "unbalanced" participants

  18 months

• Percent of number of smoked cigarettes' modification in "unbalanced" participants

  18 months

• Percent of systolic blood pressure values modification in "unbalanced" participants

  18 months

• Percent of HBA1C% values modification in "unbalanced" participants

  18 months

Study Arms (2)

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.

Other: AD Risk factors balance

Interventions

AD Risk factors balance OTHER

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.

intervention

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Previously diagnosed dementia•
• Any condition expected to limit the adherence to suggested intervention for 18 months
• Any significant neurologic or psychiatric disease

Sponsors & Collaborators

• Sheba Medical Center: lead
• Maccabi Healthcare Services, Israel: collaborator

Study Sites (1)

Sheba Medical Center

Ramat Gan, 52621, Israel

RECRUITING

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 Officials

• Ithamar Ganmore, MD, PhD

  Sheba Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ithamar Ganmore, MD, PhD

CONTACT

+972-3-5309120; itamargan@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2019
• First Posted: February 25, 2022
• Study Start: June 4, 2019
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: May 24, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Undecided yet
• Access Criteria: Undecided yet

Locations

IL (1)