U.S. Study to Protect Brain Health Through Lifestyle Intervention to Reduce Risk (POINTER)
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|ClinicalTrials.gov Identifier: NCT03688126|
Recruitment Status : Active, not recruiting
First Posted : September 28, 2018
Last Update Posted : March 30, 2023
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|Condition or disease||Intervention/treatment||Phase|
|Alzheimer Disease||Behavioral: Self-Guided Lifestyle Intervention Behavioral: Structured Lifestyle Intervention||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2000 participants|
|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|
|Actual Study Start Date :||January 8, 2019|
|Estimated Primary Completion Date :||July 2025|
|Estimated Study Completion Date :||July 2025|
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: Self-Guided
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.
- 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.
- 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.
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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|
- Sedentary (not a regular exerciser, determined using the POINTER Physical Activity Questionnaire)
- Low MIND Diet score (determined using the MIND Diet Screener)
- No cognitive impairment as per Telephone Interview for Cognitive Status (mTICS) 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 point: Suboptimum cardiovascular health (treated or untreated): systolic Blood Pressure >125 mmHg ~OR~ low-density lipoprotein (LDL) cholesterol >115 mg/dL~OR~ glycated hemoglobin (HbA1c) >6.0%1 point: First degree family history (mother, father, sister, brother) of memory impairment- 1 point: Race and ethnicity: African American/Black, Native American, or Hispanic/Latinx
1 point: Older age: 70-79 years 1 point: Sex: male
- 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
- Capacity to complete physical exercise
- Willing to complete all study-related activities for at least 24 months
- Willing to be randomized to either lifestyle intervention group
- Age <60 or ≥80 years
- 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 Diagnostic and Statistical Manual (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 New York Heart Association (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 transient ischemic attack (TIA) or small vessel stroke in the last 6 months; TIA occurring more than 6 months ago with residual effects
- 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; long-term endocrine therapy for breast cancer is allowed (e.g., tamoxifen, anastrozole)
- 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
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
|United States, California|
|Sacramento, California, United States, 95616|
|United States, Illinois|
|Chicago, Illinois, United States, 60304|
|Chicagoland--Advocate Aurora Health|
|Downers Grove, Illinois, United States, 60068|
|United States, North Carolina|
|Winston-Salem, North Carolina, United States, 27157|
|United States, Rhode Island|
|New England--Rhode Island|
|Providence, Rhode Island, United States, 02906|
|United States, Texas|
|Houston, Texas, United States, 77030|
|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|
|Responsible Party:||Wake Forest University Health Sciences|
|Other Study ID Numbers:||
|First Posted:||September 28, 2018 Key Record Dates|
|Last Update Posted:||March 30, 2023|
|Last Verified:||March 2023|
|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|
Central Nervous System Diseases
Nervous System Diseases