Simple Goal-Setting may cut Alzheimer's risk in midlife

NCT ID NCT05980052

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 17, 2026 · Last updated Jul 17, 2026

Summary

This study tests whether specific goal-setting techniques can help adults aged 45 to 65 become more physically active and stick with it. Participants are overweight or obese and currently get little exercise. They will receive a behavioral program designed to boost self-regulation and physical activity, with the long-term aim of reducing the risk of Alzheimer's disease and related dementias.

What this could mean

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

Active substance
a behavioral program that uses goal-setting techniques to help people become more physically active
What this could lead to
If successful, this approach could help midlife adults maintain regular physical activity, potentially reducing their risk of Alzheimer's disease and related dementias.
What could go wrong
This is an early proof-of-concept study with a modest sample size, so results may not apply broadly. The intervention focuses on behavior change, which can be difficult to sustain long-term.

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

About 144 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2023

Expected to finish

May 2027

An estimate. End dates often move.

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

45 to 65 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: * Aged 45 to 65 years * BMI between 30 kg/m2 to 50 kg/m2 * Participants must weigh a minimum of 110 pounds * Engaging in 60 minutes or less of self-reported moderate-to-vigorous physical activity at screening (based on Exercise Vital Sign Questionnaire) * Self-reported ownership of a smartphone with an iOS or Android operating system (necessary for participants to track their activity using a Fitbit activity monitor) Exclusion Criteria: * Endorsing an item on the Physical Activity Readiness Questionnaire (PAR-Q), unless a physician's note is provided * Resting blood pressure greater than 200/110 mmHG as assessed at the baseline study assessment (unless a physician's note is provided) * Pregnant or planning to become pregnant in next 8-months (Phase 1) or 12 months (Phase 2) * Plans to relocate out of metropolitan Phoenix, Arizona area in the next 8-months (Phase 1) or 12 months (Phase 2) * Participation in another physical activity, nutrition or weight loss program at time of screening or at any time during the intervention * Individuals with mild cognitive impairment (MCI), as determined by either a self-report of receiving a diagnosis of MCI from a health care provider or as assessed by the Montreal Cognitive Assessment (MoCA) at the study orientation session. A score \< 26 is an exclusion criterion for US born participants. A score of \<23 is an exclusion for participants born outside of the US who completed their high school education in a country where English is not the primary language. * Being previously prescribed one of the 5 approved Alzheimer's medications, including: Donepezil (Aricept), Rivastigmine (Exelon), Galantamine (Razadyne), Memantine (Namenda), Memantine + Donepezil (Namzaric) * Score of 16 or higher on the Center for Epidemiological Studies-Depression Scale (CES-D) * Self-reported current diagnosis of major depression * Currently taking 2 or more ant-depression drugs * History of stroke * Incarcerated individuals (i.e., Prisoners)

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Conditions

The condition(s) this trial relates to.

Alzheimer disease Cognitive Dysfunction dementia Motor Activity

As listed by the trial registrant

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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Arizona State University

    RECRUITING

    Phoenix, Arizona, 85004, United States

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