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

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ClinicalTrials.gov Identifier: NCT03688126
Recruitment Status : Not yet recruiting
First Posted : September 28, 2018
Last Update Posted : September 28, 2018
Sponsor:
Collaborator:
Alzheimer's Association
Information provided by (Responsible Party):
Wake Forest University Health Sciences

Brief 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.

Condition or disease Intervention/treatment Phase
Alzheimer Disease Behavioral: Self-Guided Lifestyle Intervention Behavioral: Structured Lifestyle Intervention Not Applicable

Detailed 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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Masking Description: The U.S. POINTER Coordinating Center (CC) is divided into two distinct entities: the Administrative and Clinical Operations CC and the Data CC. Investigators and staff within the Administrative and Clinical Operations CC will be masked to outcomes data. Investigators and staff within the Data CC will be unmasked to intervention assignment and outcomes. In the clinic, examiners, data entry staff, and the study clinician will be masked to intervention assignment.
Primary Purpose: Supportive Care
Official Title: U.S. Study to Protect Brain Health Through Lifestyle Intervention to Reduce Risk
Estimated Study Start Date : January 2019
Estimated Primary Completion Date : November 2023
Estimated Study Completion Date : November 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Self-Guided Lifestyle Intervention
Lifestyle modification program that is developed by the participant to meet his/her specific needs.
Behavioral: Self-Guided Lifestyle Intervention
Lifestyle intervention that involves providing participants with education, support, and tangible tools to assist them in developing and carrying out healthier lifestyle practices.
Other Name: SG

Experimental: Structured Lifestyle Intervention
Lifestyle modification program that involves participants completing structured activities that target diet, physical exercise, and intellectual and social stimulation.
Behavioral: Structured Lifestyle Intervention
Lifestyle intervention that involves a structured program of diet, physical and cognitive exercise, and management of cardiometabolic risks.
Other Name: STR




Primary Outcome Measures :
  1. Global cognitive function [ Time Frame: up to 2 years ]
    Global cognitive function will be obtained from a composite score derived from subtest scores on the POINTER modified Neuropsychological Test Battery (PmNTB) that includes: Free and Cued Selective Reminding Test, Story Recall, Visual Paired Associates, Number Span, Word Fluency, Trail-Making Test, and Digit Symbol Substitution Test. Scores from each individual test will be converted to z-scores that typically range from -3 to 3, with higher scores reflecting better performance, and averaged to form a composite. The primary outcome is the slope of these composite scores over repeated assessments (standard deviation units per year), with less negative (or positive) slopes reflecting better performance.


Secondary Outcome Measures :
  1. Episodic Memory [ Time Frame: up to 2 years ]
    This will be a composite score from PmNTB subtests Free and Cued Selective Reminding Test, Story Recall, Visual Paired Associates; and experimental measures: Cogstate One-Card Learning, Face Name Associative Memory Exam, and Behavioral Pattern Separation of Objects, calculated in a manner parallel to how the primary composite outcome is calculated. This secondary outcome is the slope of these composite scores over time (standard deviation units per year) with less negative (or positive) slopes reflecting better performance.

  2. Executive Function [ Time Frame: up to 2 years ]
    This will be a composite score from PmNTB subtests Number Span, Word Fluency, Trail-Making Test Part B, Digit Symbol Substitution Test; and experimental measures: Cogstate One Back, and Digital Clock Drawing Test, calculated in a manner parallel to the primary composite outcome is calculated. This secondary outcome is the slope of these composite scores over time (standard deviation units per year) with less negative (or positive) slopes reflecting better performance.

  3. Processing Speed [ Time Frame: up to 2 years ]
    This will be a composite score from PmNTB subtests Trail-Making Test Part A and Digit Symbol Substitution Test; and experimental measures: Cogstate Detection and Identification, and Digital Clock Drawing Test calculated in a manner parallel to the primary composite outcome is calculated. This secondary outcome is the slope of these composite scores over time (standard deviation units per year) with less negative (or positive) slopes reflecting better performance.

  4. Clinical Dementia Rating—Sum of Boxes [ Time Frame: up to 2 years ]
    The Clinical Dementia Rating (CDR) is a clinical scale that rates the severity of dementia as absent, questionable, mild, moderate, or severe (CDR score of 0, 0.5, 1, 2, or 3, respectively) across six domains. Scores from these domains are summed ranging from 0 to 18, with higher scores reflecting worse performance. The secondary outcome will be the change in the mean scores from baseline to 2 years.

  5. Instrumental Activities of Daily Living (IADL) [ Time Frame: up to 2 years ]
    The Lawton-Brody IADL is a commonly used scale in clinical practice and research that assess a person's functional ability to complete tasks such as shopping, food preparation, transportation, and managing finances. Scores range from 0 to 8 for women and from 0 to 5 for men, with higher scores reflecting better performance. The secondary outcome will be the change in the mean scores from baseline to 2 years.

  6. Everyday Cognition (ECog) [ Time Frame: up to 2 years ]
    The ECog is a validated scale developed to assess everyday functional status. The short form of the instrument will be used in U.S. POINTER. Scores range from 0 to 4 with higher scores reflecting greater poorer function. The secondary outcome will be the change in the mean scores from baseline to 2 years.

  7. Digital Clock Drawing Test (DCTClock) [ Time Frame: up to 2 years ]
    DCTClock assesses cognition via novel software that processes information from a commercially available digital pen. This software is able to capture nuances in cognitive performance. Many metrics can be generated with this device. The secondary outcome for U.S. POINTER will be time (in seconds) to completion of the clock drawing test, with longer times reflecting poorer processing speed. The secondary outcome will be the change in the mean scores from baseline to 2 years.

  8. Lifestyle Composite [ Time Frame: up to 2 years ]
    This composite score is based on self-reported Physical Activity Questionnaire, Rush Food Frequency Questionnaire, and the Cognitive Activity Questionnaire. Participants will be ordered with respect to each index, with higher scores reflecting 1) greater daily physical activity, 2) greater conformance with the MIND Diet, and 3) greater cognitive activity. Based on these orderings, participants will be assigned percentiles with respect to each measure relative to the overall group. These percentiles will range from 0 to 100. The secondary outcome will be the average of the three percentiles. The secondary outcome will be the change in the mean scores from baseline to 2 years.



Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03688126


Contacts
Contact: Wilson Somerville 336-716-6177 wsomerv@wakehealth.edu
Contact: Laura D Baker, PhD 336-713-8831 ldbaker@wakehealth.edu

Locations
United States, California
U.C. Davis Not yet recruiting
Davis, California, United States, 95616
Contact: Rachel A Whitmer, PhD       rawhitmer@ucdavis.edu   
Principal Investigator: Rachel A Whitmer, PhD         
Principal Investigator: Sarah Farias, PhD         
United States, North Carolina
Wake Forest School of Medicine Not yet recruiting
Winston-Salem, North Carolina, United States, 27157
Contact: Elizabeth Chmelo, MS    336-716-3733    echmelo@wakehealth.edu   
Contact: Wilson Somerville    336-716-6177    wsomerv@wakehealth.edu   
Principal Investigator: Jeff Williamson, MD         
Sponsors and Collaborators
Wake Forest University Health Sciences
Alzheimer's Association
Investigators
Principal Investigator: Laura D Baker, PhD Wake Forest University Health Sciences
Principal Investigator: Mark A Espeland, PhD Wake Forest University Health Sciences
Principal Investigator: Rachel A Whitmer, PhD University of California, Davis
Principal Investigator: Miia Kivipelto, MD, PhD Karolinska Institutet

Publications:
Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT03688126     History of Changes
Other Study ID Numbers: IRB00052881
First Posted: September 28, 2018    Key Record Dates
Last Update Posted: September 28, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: The data will be released to national databases upon completion of the study. Links to these databases will be provided at a later time.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Wake Forest University Health Sciences:
cognitive decline
dementia
cognitive function

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders