Recruiting

Lifestyle Change

Sponsor:

University of Kansas Medical Center

Code:

NCT05985486

Conditions

Down Syndrome

Alzheimer Disease

Obesity

Eligibility Criteria

Sex: All

Age: 18 - 64

Healthy Volunteers: Not accepted

Interventions

Diet

Health Education

Study Details

Brief summary:

The goal of this study is to determine if weight loss or changes in dietary intake can help prevent of delay adults with Down syndrome from developing Alzheimer's Disease

Adults with Down syndrome without dementia will be randomized to either a weight loss group or a general health education control group. The weight loss group will be asked to follow a reduced energy diet, attend monthly education sessions delivered remotely and self-monitor diet and body weight using commercially available web-based applications. The control group will be asked to attend remotely delivered monthly education sessions on general health education topics.

All participants will come to the University of Kansas Medical Center, 3 times across 12 months for a blood draw, cognitive testing, a MRI, assessment of height and weight, and assessment of diet intake.

Conditions

Down Syndrome

Alzheimer Disease

Obesity

Study ID

NCT05985486

Start date

Oct 22, 2024

Status verified date

Mar, 2026

Completion date

Sep 30, 2027

Anticipated

Primary completion date

Sep 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 64

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Diagnosis of Down syndrome
  • BMI of 25 to 50 kg/m2
  • Ability to communicate through spoken language.
  • Ability to come to the University of Kansas Medical Center 3 times across 1 year for outcomes testing
  • Living at home with a parent/guardian, or in a supported living environment with a caregiver who assists with food shopping, meal planning, and meal preparation and agrees to serve as a study partner including providing transportation to our facilities for study assessments.

Exclusion Criteria:

  • Diagnosis of dementia
  • Insulin dependent diabetes
  • Participation in a weight management program involving diet or physical activity in the past 6 mos.
  • Dairy allergy
  • Serious medical risk (e.g., cancer, recent heart attack, stroke, pregnancy, angioplasty)
  • Unwilling to be randomized
  • Contraindications for MRI, including metal implants or devices incompatible with MRI such as pacemakers, claustrophobia, and inability to lay in a supine position
  • Use of GLP-1 medications
  • Use of anti-amyloid medications

Study Design

Enrollment

81 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Weight Loss

  • Follow a reduced calorie diet daily for 12 months.
  • Attend monthly behavioral counseling/education

active comparator: General Health Education Control

\- Attend monthly health education sessions about general health.

Interventions

Diet

A reduced calorie diet which uses frozen meals purchased at the store and focuses on increasing fruits and vegetables associated with brain health.

Health Education

Monthly health education sessions delivered remotely.

Primary outcome measure

  • Plasma Amyloid beta 42:40 ratio [ Time Frame: Baseline, 6, 12 months ]
  • Neurofilament light [ Time Frame: Baseline, 6, 12 months ]
  • Weight [ Time Frame: Baseline, 6, 12 months ]

Central Contacts and Locations

Central contacts

Lauren Ptomey, PhD

913-588-7982lptomey@kumc.edu

Jessica Danon

785-764-3574jdanon@kumc.edu

Locations

University of Kansas Medical Center

Recruiting

Kansas City, Kansas, United States, 66160

More Information

Sponsor

University of Kansas Medical Center

Last update posted

Mar 11, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Kansas Medical Center on 2026-03-11.