97 Participants Needed

Lifestyle Intervention with Coaching for Cognitive Impairment

(PREVENTION Trial)

JR
JB
Overseen ByJennifer Bramen, PhD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

The PREVENTION Trial is a 12-month, two-arm randomized clinical trial (RCT) in adults 50-80 years old experiencing cognitive decline. Our study clinicians will refer patients for enrollment based on three categories: 1) a diagnosis of mild AD according to criteria established by the National Institute of Neurological and Communicative Disorders and Stroke (AD and Related Disorders Association \[NINCDS-ADRDA\]), 2) those with mild cognitive impairment will be diagnosed according to the Petersen method, and 3) subjective memory impairment as assessed by neuropsychological assessments and self-report. Enrollment will require evidence of AD pathophysiological processes (as defined by a positive amyloid positron emission tomography (PET) scan).The first objective is to evaluate the efficacy of a coached, data-driven, multi-modal lifestyle intervention to treat cognitive decline. Subjects will be randomized into one of two groups: Group 1 (Active Control) or Group 2 (Intervention). Group 1 (Data-driven clinical recommendations (CR)) will serve as the active control group and will receive data-driven clinical recommendations by a study physician based on study assessments and clinical lab values. Group 2 (Data-driven multi-modal intervention with coaching (MMIC)) will receive the same clinical recommendations and also an intensive multi-modal intervention with health coaching, support and resources to carry out these recommendations. This includes health coaching sessions (with an RDN), dietary counseling sessions (with an RDN), and group cognitive and physical exercise classes (CogFit) with a certified personal trainer and a computer-based neurocognitive program at home. Both groups will be measured for treatment related changes in cognitive and functional abilities, quality of life, biological, and biochemical measures.The second objective is to analyze longitudinal multi-omic data, including metabolomics, proteomics, genetics, microbiome, behavior and cognition into personalized, dense, dynamic data (i.e. PD3) from individuals with cognitive decline and underlying Alzheimer's neuropathology. The goal analysis is to identify models of causation that can further advance knowledge and research in neurodegenerative disorders and healthy living.

Are You a Good Fit for This Trial?

Adults aged 50-80 with mild Alzheimer's Disease, mild cognitive impairment, or subjective memory complaints are eligible. They must be proficient in English, stable on medications for chronic conditions, able to use a computer and the Internet, and willing to undergo an amyloid PET scan showing evidence of AD pathology.

Inclusion Criteria

My gender, race, or ethnicity does not limit my participation.
Subjects, with or without assistance, must be able to use a computer and web interface. If assistance is needed, it must be readily available to them.
I have a caregiver or legal representative to accompany me for my treatments.
See 12 more

Exclusion Criteria

You have a high score on a test for dementia.
I or my immediate family have a high-risk gene mutation for Alzheimer's.
I have been diagnosed with a neurodegenerative disorder that is not Alzheimer's.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized into two groups: Group 1 receives data-driven clinical recommendations, and Group 2 receives a multi-modal intervention with coaching.

12 months
Regular visits for coaching and assessments

Follow-up

Participants are monitored for changes in cognitive and functional abilities, quality of life, and biological measures after treatment.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Coached Data-Driven Clinical Recommendations
  • Data-Driven Clinical Recommendations
Trial Overview The trial tests two approaches over 12 months: one group receives data-driven clinical recommendations (Active Control), while the other gets these plus a coached multi-modal lifestyle intervention including health coaching sessions, dietary counseling, exercise classes (CogFit), and at-home neurocognitive programs.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Group 2 - Data-driven coached multi-modal intervention (MMIC)Experimental Treatment1 Intervention
Group II: Group 1 - Data-driven clinical recommendations (CR)Active Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

John Wayne Cancer Institute

Lead Sponsor

Trials
22
Recruited
5,500+

Saint John's Cancer Institute

Lead Sponsor

Trials
27
Recruited
6,800+

Institute for Systems Biology

Collaborator

Trials
4
Recruited
330+

St. Joseph's Healthcare Foundation

Collaborator

Trials
6
Recruited
380+
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security