Summary

for people ages 60-79 (full criteria)
at UC Davis
study started
estimated completion
Rachel A Whitmer (ucdavis)

Description

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.

Details

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.

Keywords

Alzheimer Disease cognitive decline dementia cognitive function Self-Guided Lifestyle Intervention Structured Lifestyle Intervention

Eligibility

You can join if…

Open to people ages 60-79

  • Sedentary
  • Poor diet
  • First-degree family history of a significant memory impairment (if unknown, participant is ineligible)
  • Cognitive function: no cognitive impairment
  • Lives in a region where the POINTER interventions will be delivered
  • Does not plan to travel outside of the home geographic area for more than 3 months over the course of the study
  • Free of physical disabilities that preclude participation in the study
  • Willing to complete all study-related activities for 24 months
  • Willing to be randomized to either lifestyle intervention group

You CAN'T join if...

  • Body mass index (BMI) >40
  • Systolic blood pressure (BP), hemoglobin A1c (HbA1c), and lipids all conform to current health guidelines for age (systolic BP <130mmHG; low-density lipoprotein (LDL) cholesterol <130mg/dL; HbA1c <6.0%)
  • Any significant neurologic disease, including any form of dementia, mild cognitive impairment, Parkinson's disease, Huntington's disease, normal pressure hydrocephalus, brain tumor, progressive supranuclear palsy, seizure disorder, subdural hematoma, multiple sclerosis, or history of significant head trauma with persistent neurologic sequelae or known structural brain abnormalities
  • Current or past use of medications for memory impairment or Alzheimer's disease (e.g., cholinesterase inhibitors, memantine)
  • History of major depression within the last 12 months
  • History of bipolar disorder or schizophrenia as per Diagnostic and Statistical manual (DSM) V criteria
  • History of alcohol or substance abuse or dependence within the past 2 years
  • Use of psychoactive medications within the last 3 months including tricyclic antidepressants, antipsychotics, mood-stabilizing psychotropic agents (e.g., lithium salts), psychostimulants, opiate analgesics, antiparkinsonian medications, anticonvulsant medications (except gabapentin and pregabalin for non-seizure indications), systemic corticosteroids, or medications with significant central anticholinergic activity; in the absence of major depression, stable dose use of selective serotonin reuptake inhibitors or serotonin and norepinephrine reuptake inhibitors are allowed
  • Significant cardiovascular disease (including 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 (>3mm) 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 transient ischemia attack (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 (inhaled steroids for asthma is permissible)
  • Renal disease
  • 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 posttreatment
  • 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
  • For women: currently pregnant, pregnant within the past 6 months, or planning to become pregnant within the next 6 months.
  • Resides in an assisted living facility or nursing home
  • Receives hospice care
  • Site PI/Study Clinician discretion regarding appropriateness of participation or concern about intervention adherence

Locations

  • U.C. Davis not yet accepting patients
    Davis California 95616 United States
  • Wake Forest School of Medicine accepting new patients
    Winston-Salem North Carolina 27157 United States

Lead Scientist

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Wake Forest University Health Sciences
ID
NCT03688126
Study Type
Interventional
Last Updated