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

Sheba Medical Center

Status: Enrolling

Conditions: Alzheimer Disease

Treatments: Other: AD Risk factors balance

Study type: Interventional

Funder types: Other

Identifiers

NCT05256121

SHEBA-18-5744-IG-CTIL

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 40 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• • 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

Exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

control

No Intervention group

Description:

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 group

Description:

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.

Treatment:

Other: AD Risk factors balance