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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 : Recruiting
First Posted : September 28, 2018
Last Update Posted : August 4, 2020
Sponsor:
Collaborator:
Alzheimer's Association
Information provided by (Responsible Party):
Wake Forest University Health Sciences

Tracking Information
First Submitted Date  ICMJE September 26, 2018
First Posted Date  ICMJE September 28, 2018
Last Update Posted Date August 4, 2020
Actual Study Start Date  ICMJE January 8, 2019
Estimated Primary Completion Date November 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 26, 2018)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 26, 2018)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE U.S. Study to Protect Brain Health Through Lifestyle Intervention to Reduce Risk
Official Title  ICMJE U.S. Study to Protect Brain Health Through Lifestyle Intervention to Reduce Risk
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Alzheimer Disease
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • Experimental: Self-Guided Lifestyle Intervention
    Lifestyle modification program that is developed by the participant to meet his/her specific needs.
    Intervention: Behavioral: Self-Guided Lifestyle Intervention
  • Experimental: Structured Lifestyle Intervention
    Lifestyle modification program that involves participants completing structured activities that target diet, physical exercise, and intellectual and social stimulation.
    Intervention: Behavioral: Structured Lifestyle Intervention
Publications * Ngandu T, Lehtisalo J, Solomon A, Levälahti E, Ahtiluoto S, Antikainen R, Bäckman L, Hänninen T, Jula A, Laatikainen T, Lindström J, Mangialasche F, Paajanen T, Pajala S, Peltonen M, Rauramaa R, Stigsdotter-Neely A, Strandberg T, Tuomilehto J, Soininen H, Kivipelto M. A 2 year multidomain intervention of diet, exercise, cognitive training, and vascular risk monitoring versus control to prevent cognitive decline in at-risk elderly people (FINGER): a randomised controlled trial. Lancet. 2015 Jun 6;385(9984):2255-63. doi: 10.1016/S0140-6736(15)60461-5. Epub 2015 Mar 12.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 26, 2018)
2000
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 2023
Estimated Primary Completion Date November 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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:

    1 pt: Suboptimum cardiovascular health (treated or untreated): systolic BP >125 mmHg ~OR~ LDL cholesterol >115 mg/dL~OR~ glycated hemoglobin (HbA1c) >6.0%

    1 pt: First degree family history (mother, father, sister, brother) of memory impairment

    1 pt: Race/ethnicity: African American/Black, Native American, or Hispanic/Latinx

    1 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 60 Years to 79 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Wilson Somerville 336-716-6177 wsomerv@wakehealth.edu
Contact: Laura D Baker, PhD 336-713-8831 ldbaker@wakehealth.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03688126
Other Study ID Numbers  ICMJE IRB00052881
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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.
Responsible Party Wake Forest University Health Sciences
Study Sponsor  ICMJE Wake Forest University Health Sciences
Collaborators  ICMJE Alzheimer's Association
Investigators  ICMJE
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
PRS Account Wake Forest University Health Sciences
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP