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

Last updated: May 22, 2022
Sponsor: Sheba Medical Center
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT05256121
SHEBA-18-5744-IG-CTIL
  • Ages 40-65
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • • Age 40-65 at enrollment to the study
  • Family history of AD-All subjects recruited will have at least 1 parent diagnosedwith 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;
  1. type 2 diabetes [T2D]; 3. Hypertension; 4. obesity/ overweight; 5. lowphysical inactivity; 6. low educational attainment/ mental activity; 7.depression)
  • No dementia diagnosis
  • Hebrew fluency

Exclusion

Exclusion Criteria:

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

Study Design

Total Participants: 100
Study Start date:
June 04, 2019
Estimated Completion Date:
December 31, 2024

Study 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.

Connect with a study center

  • Sheba Medical Center

    Ramat Gan, 52621
    Israel

    Active - Recruiting

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