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

What Is This Study About?

The purpose of this study is to see if lifestyle changes, such as exercise, diet, and cognitively stimulating activities, can protect memory and thinking in older adults who are at an increased risk of significant memory loss. In this two-year study, people will be randomly assigned to participate in one of two lifestyle modification programs. Researchers will compare results of people who are given the education, support, and tools to develop and carry out healthier lifestyle practices with people who are assigned to a structured program of diet, physical and cognitive exercise, and management of cardiometabolic risks.

Do I Qualify To Participate in This Study?

Must have:

• Sedentary
• Poor diet
• First-degree family history of a significant memory impairment (such as parent or sibling)
• No cognitive impairment
• Does not plan to travel for more than three months over the course of the study
• Free of physical disabilities that would interfere with participation

Must NOT have:

• Body mass index of 40 or more
• Systolic blood pressure less than 130 mmHg, hemoglobin A1c less than 6%, and low-density lipoprotein less than 130 mg/dl
• Any significant neurologic disease, including  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 effects
• Prohibited medications:
  • Current or past use of Alzheimer's disease medications, including cholinesterase inhibitors and memantine
  • Psychoactive medications within last three 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 conditions), systemic corticosteroids, or medications with significant central anticholinergic activity
  • Past or current use of insulin to treat type 2 diabetes
• Major depression within past year
• History of bipolar disorder or schizophrenia
• Alcohol or substance abuse or dependence within past two years
• 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 (such as third-degree heart block), uncontrolled arrhythmia, or new Q waves or ST-segment depressions (greater than 3 mm) on electrocardiogram
• Heart attack, major heart surgery (such as valve replacement, bypass surgery, stent placement, or angioplasty), deep vein thrombosis, or pulmonary embolus in past six months
• Large vessel stroke in the past two years
• History of transient ischemia attack (TIA) or small vessel stroke in the last six months, or TIA occurring more than six months ago with residual effects
• Lung disease requiring either regular use of corticosteroids or supplemental oxygen (inhaled steroids for asthma permissible)
• Kidney disease
• Significant abnormalities in laboratory blood tests
• History within the last two 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 six months
• Currently receiving physical therapy or cardiopulmonary rehabilitation
• History of a malabsorptive bariatric procedure, such as gastric bypass or biliopancreatic diversion; other bariatric procedures involving restriction, including a sleeve or band, are allowed
• If female, currently pregnant, pregnant within the past six months, or planning to become pregnant within the next six months
• Residing in an assisted living facility or nursing home
• Receiving hospice care

If I Qualify, Who Do I Contact?

Contact study personnel listed either under the general study contact or the location nearest you.

 

Who Is the General Study Contact?

For more information about this study, visit the U.S. POINTER website.

Where Is This Study Located?

Who Sponsors This Study?

Lead: Wake Forest University Health Sciences

Collaborator Sponsor

• Alzheimer's Association

Source: ClinicalTrials.gov ID: NCT03688126