U.S. Study to Protect Brain Health Through Lifestyle Intervention to Reduce Risk

  • STATUS
    Recruiting
  • End date
    Dec 17, 2024
  • participants needed
    2000
  • sponsor
    Wake Forest University Health Sciences
Updated on 17 February 2021
cognitive impairment
dementia
cognitive decline
amnesia

Summary

The purpose of this research study is to see if lifestyle changes can protect memory and thinking (cognition) as we age. A recent study in Finland found that a combination of physical and cognitive exercise, diet, and social activity protected cognitive function in healthy older adults who were at increased risk of significant memory loss. So far no medications can rival this positive outcome. The point of POINTER is to test if lifestyle change can also protect against memory loss in Americans.

Description

Lifestyle interventions focused on combining healthy diet, physical activity, and social and intellectual challenges may represent a promising therapeutic strategy to protect brain health. The recent results of the population-based 2-year clinical trial, Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability (FINGER), indicated that a multidomain intervention of physical activity, nutritional guidance, cognitive training, social activities, and management of heart health risk factors protected cognitive function in healthy older adults at increased risk of cognitive decline. As yet, there are no pharmacological treatment options that can rival this effect. Thus, there is an urgent need to expand this work to test the generalizability, adaptability and sustainability of its findings in diverse and global populations. This pivotal U.S. Study to Protect Brain Health through Lifestyle Intervention to Reduce Risk (U.S. POINTER) will test whether a similar 2-year intensive lifestyle intervention, adapted to American culture and delivered within the community, can protect cognitive function in older adults in the U.S. who are at increased risk for cognitive decline and dementia. If successful, the results of this study will have large-scale implications for public policy regarding standard of clinical care and prescriptive practices for a fast-growing and vulnerable population of older adults.

Details
Condition Dementia, Alzheimer's Disease, alzheimer, dementia alzheimer's type
Treatment Self-Guided Lifestyle Intervention, Structured Lifestyle Intervention
Clinical Study IdentifierNCT03688126
SponsorWake Forest University Health Sciences
Last Modified on17 February 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 60 yrs and 79 yrs?
Gender: Male or Female
Do you have any of these conditions: Dementia or Alzheimer's Disease?
Do you have any of these conditions: Dementia or alzheimer or dementia alzheimer's type or Alzheimer's Disease?
Do you have any of these conditions: Dementia or dementia alzheimer's type or alzheimer or Alzheimer's Disease?
Do you have any of these conditions: Alzheimer's Disease or dementia alzheimer's type or alzheimer or Dementia?
Sedentary (not a regular exerciser, determined using the POINTER Physical Activity Questionnaire)
Poor diet (as per the MIND Diet Screener)
No cognitive impairment as per TICSm score >32 (includes adjustments for demographics such as age, education and race), the Clinical Dementia Rating Scale (CDR <0.5), and the CDR-Sum of Boxes (CDR-SB <1)
Risk Score for cognitive decline >2, using the following scoring algorithm
pt: Suboptimum cardiovascular health (treated or untreated): systolic BP
>125 mmHg ~OR~ LDL cholesterol >115 mg/dL~OR~ glycated hemoglobin (HbA1c)
>6.0%
pt: First degree family history (mother, father, sister, brother) of memory
impairment
pt: Race/ethnicity: African American/Black, Native American, or
Hispanic/Latinx
pt: Older age: 70-79 years
Lives in a region where the POINTER interventions will be delivered
Does not plan to travel outside of the home geographic area for an extended period of time during study participation
Free of physical disabilities that preclude participation
Willing to complete all study-related activities for 24 months
Willing to be randomized to either lifestyle intervention group

Exclusion Criteria

Age <60 or 80 years
BMI >40
Any significant neurologic disease, including any form of dementia, mild cognitive impairment, Parkinson's disease, Huntington's disease, normal pressure hydrocephalus, progressive supranuclear palsy, seizure disorder, subdural hematoma, multiple sclerosis, or history of significant head trauma with persistent neurologic sequelae or known structural brain abnormalities
History of major depression within the last 6 months
History of bipolar disorder or schizophrenia as per DSM V criteria
History of alcohol or substance abuse or dependence within the past 2 years, as per DSM V criteria
Current or past use of medications for memory impairment or AD (e.g., cholinesterase inhibitors, memantine)
Current daily use of systemic corticosteroids
Current use of 3 or more doses of narcotics/week. Use of intermittent narcotics should be stopped 48 hours prior to clinic visits/cognitive testing. Tramadol is allowed as long as the dose remains stable for 3 months
Use of psychoactive medications, including benzodiazepines, tricyclic antidepressants, antipsychotics, mood-stabilizers, psychostimulants, anti-parkinsonian medications, anticonvulsant medications or medications with significant central anticholinergic activity are allowed as long as the medication is NOT used to treat an exclusionary medical condition
Significant cardiovascular disease (including NYHA Class III or IV congestive heart failure, clinically significant aortic stenosis, history of cardiac arrest, or uncontrolled angina)
Serious conduction disorder (e.g., 3rd degree heart block), uncontrolled arrhythmia, or new Q waves or ST-segment depressions (>3 mm) on ECG (treated atrial fibrillation for more than 1 year or occasional premature ventricular contractions on ECG are not exclusions)
Myocardial infarction, major heart surgery (i.e., valve replacement, bypass surgery, stent placement, angioplasty), deep vein thrombosis, or pulmonary embolus in the past 6 months
Large vessel stroke in the past 2 years
History of TIA or small vessel stroke in the last 6 months; TIA occurring more than 6 months ago with residual effects
Past or current use of insulin to treat type 2 diabetes
Lung disease requiring either regular use of corticosteroids or the use of supplemental oxygen; intermittent use of corticosteroids or supplemental oxygen to treat chronic obstructive pulmonary disease exacerbation is allowed; use of inhaled steroids for asthma is allowed
End stage renal disease (e.g., requiring dialysis or as per clinician discretion)
Clinically significant abnormalities in laboratory blood tests as per judgment of the site Study Clinician
History within the last 2 years of treatment for primary or recurrent malignant disease, excluding non-melanoma skin cancers, resected cutaneous squamous cell carcinoma in situ, basal cell carcinoma, cervical carcinoma in situ, or in situ prostate cancer with normal prostate-specific antigen post-treatment
History of hip fracture, joint replacement, or spinal surgery in the last 6 months
Currently receiving physical therapy or cardiopulmonary rehabilitation
History of a malabsorptive bariatric procedure (gastric bypass, biliopancreatic diversion); other bariatric procedures involving restriction (i.e., sleeve, band) are not exclusionary
Resides in an assisted living facility or nursing home
Receives hospice care
Site PI/Study Clinician discretion regarding medical status, appropriateness of participation or concern about intervention adherence
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