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Lifestyle overhaul may shield aging brains from memory loss

NCT ID NCT03688126

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether lifestyle changes—like a healthy diet, physical and mental exercise, and managing health risks—can protect memory and thinking in older adults at risk for Alzheimer's disease. Researchers enrolled 2,000 Americans who were sedentary and had a low-quality diet but no memory problems. Participants were split into two groups: one received tools and support to make their own lifestyle changes, while the other followed a structured program. The goal was to see if these changes could slow or prevent cognitive decline.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Lifestyle intervention (diet, physical and cognitive exercise, social activity, and cardiometabolic risk management)
What this could lead to
If successful, this could show that lifestyle changes can help prevent memory loss and cognitive decline in older Americans at risk for Alzheimer's disease.
What could go wrong
This is a completed study, but results may not apply to everyone. Lifestyle changes can be hard to maintain, and the effect may be modest or not work for all individuals.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

2,000 people

The number who actually took part.

Started

Jan 2019

Finished

May 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

60 to 79 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Sedentary (not a regular exerciser, determined using the POINTER--modified Telephone Assessment of Physical Activity \[TAPA\] * 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, Middle Eastern/North African, 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 Exclusion Criteria * 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

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Chicagoland--Advocate Aurora Health

    Downers Grove, Illinois, 60068, United States

  • Chicagoland--Rush

    Chicago, Illinois, 60304, United States

  • Houston

    Houston, Texas, 77030, United States

  • New England--Rhode Island

    Providence, Rhode Island, 02906, United States

  • North Carolina

    Winston-Salem, North Carolina, 27157, United States

  • Northern California

    Sacramento, California, 95616, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.