Down SyndromeBOLDNCT05985486
Brain Outcomes With Lifestyle Change in Down Syndrome
A study testing Diet and Health Education in people with Down Syndrome and Alzheimer Disease, run by University of Kansas Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Down Syndrome, Alzheimer Disease, Obesity
- What is being tested?
- Diet and Health Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Oct 2024to 30 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Kansas Medical Center
Kansas City, Kansas, 66160
Lauren Ptomey, PhD
About this study
Official title: The Impact of Weight Loss on Alzheimer's Disease Risk in Adults With Down Syndrome
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
- Being tested
- Diet, Health Education
- Medical subject headings
- Down Syndrome, Alzheimer Disease, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DietBehavioural
A reduced calorie diet which uses frozen meals purchased at the store and focuses on increasing fruits and vegetables associated with brain health.
Health EducationBehavioural
Monthly health education sessions delivered remotely.
| Study group | Role | What they receive |
|---|---|---|
| Weight Loss | Experimental | * Follow a reduced calorie diet daily for 12 months.
* Attend monthly behavioral counseling/education Receives: Behavioral: Diet; Behavioral: Health Education |
| General Health Education Control | Active comparator | - Attend monthly health education sessions about general health. Receives: Behavioral: Health Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma Amyloid beta 42:40 ratio
Examines the amount of amyloid beta in a person's brain, measured by a blood draw.
Measured: Baseline, 6, 12 months
Neurofilament light
Examines the amount of Neurofilament light in a person's brain, measured by a blood draw.
Measured: Baseline, 6, 12 months
Weight
Examines how much a person weights, measured by standing on a scale.
Measured: Baseline, 6, 12 months
Secondary outcomes (9)
Dietary Intake
Examines what someone is eating, measured by writing down what a person eats over 3 days.
Measured: Baseline, 6, 12 months
Skin carotenoid content
Examines how many vegetables a person eats, measured by a finger scan using the Veggie Meter.
Measured: Baseline, 6, 12 months
Plasma Phosphorylated Tau
Examines the amount of Tau in a person's brain, collected by a blood draw.
Measured: Baseline, 6, 12 months
Glial Fibrillary Acidic Protein
Examines the amount of Glial Fibrillary Acidic Protein in a person's brain, collected by a blood draw.
Measured: Baseline, 6, 12 months
Brian Volume
Examines how much white and grey matter a person has in their brain, measured by MRI
Measured: Baseline, 12 months
Brain antioxidants
Examines the amount of GHS and vitamin C a person has in their brain. Measured by MRI
Measured: Baseline, 12 months
The modified Cued Recall Test
Measures cognitive function. Twelve items are presented for learning, 4 at a time, with each item accompanied by a unique category cue. The testing phase consists of 3 trials. Each trial begins with free recall of the test items; following free recall, a category cue is provided for those items not spontaneously recalled.
Measured: Baseline, 6, 12 months
The Modified Cats and Dogs Task
Measures executive function. The task measures the ability to inhibit a natural response (naming the pictures of a dog, as "dog") and to replace it with an incongruent one (naming the pictures of a dog as "cat").
Measured: Baseline, 6, 12 months
Down Syndrome Mental Status Examination
Provides an omnibus measure of neuropsychological functioning, assessing recall of personal information, orientation, immediate and delayed memory, language, visuospatial function and praxis.
Measured: Baseline, 6, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start22 Oct 2024
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Down SyndromeStudies of the same condition, open and under way.
- More trials run by University of Kansas Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 81 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05985486
- Sponsor's protocol ID
- Study 150542
- Acronym
- BOLD
- Status last verified
- Mar 2026
- First submitted
- 2 Aug 2023
- Last updated
- 11 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ptomey LT, Donnelly JE, Burns J, Morris J, Hartley S, Martin LE, Choi IY, Lee P, Li Y, Hunt S, Sherman JR, Danon JC, Brucks MG, Koon L, Spaeth K, Sullivan DK. Brain outcomes with lifestyle change in adults with Down syndrome: Rationale and design for a 12-month randomized trial. Alzheimers Dement. 2025 Apr;21(4):e70219. doi: 10.1002/alz.70219.
PubMed 40329624
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Weight Loss on Alzheimer's Disease Risk in Adults With Down Syndrome
- ClinicalTrials.gov ID
- NCT05985486
- Acronym / sponsor ID
- BOLD / Study 150542
- Conditions
- Down Syndrome, Alzheimer Disease, Obesity
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 81 participants (estimated)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Study start
- 22 Oct 2024 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 14 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Weight Loss | Experimental | Behavioral: Diet, Behavioral: Health Education* Follow a reduced calorie diet daily for 12 months. * Attend monthly behavioral counseling/education |
| General Health Education Control | Active comparator | Behavioral: Health Education- Attend monthly health education sessions about general health. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DietA reduced calorie diet which uses frozen meals purchased at the store and focuses on increasing fruits and vegetables associated with brain health. | Behavioural | Weight Loss |
| Health EducationMonthly health education sessions delivered remotely. | Behavioural | General Health Education Control, Weight Loss |
Primary outcome
Plasma Amyloid beta 42:40 ratio
Time frame: Baseline, 6, 12 months
Examines the amount of amyloid beta in a person's brain, measured by a blood draw.
Neurofilament light
Time frame: Baseline, 6, 12 months
Examines the amount of Neurofilament light in a person's brain, measured by a blood draw.
Weight
Time frame: Baseline, 6, 12 months
Examines how much a person weights, measured by standing on a scale.
9 secondary outcomes
Dietary Intake
Time frame: Baseline, 6, 12 months
Skin carotenoid content
Time frame: Baseline, 6, 12 months
Plasma Phosphorylated Tau
Time frame: Baseline, 6, 12 months
Glial Fibrillary Acidic Protein
Time frame: Baseline, 6, 12 months
Brian Volume
Time frame: Baseline, 12 months
Brain antioxidants
Time frame: Baseline, 12 months
The modified Cued Recall Test
Time frame: Baseline, 6, 12 months
The Modified Cats and Dogs Task
Time frame: Baseline, 6, 12 months
Down Syndrome Mental Status Examination
Time frame: Baseline, 6, 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2026.
- Derived from this study: PubMed 40329624Ptomey LT, Donnelly JE, Burns J, Morris J, Hartley S, Martin LE, Choi IY, Lee P, Li Y, Hunt S, Sherman JR, Danon JC, Brucks MG, Koon L, Spaeth K, Sullivan DK. Brain outcomes with lifestyle change in adults with Down syndrome: Rationale and design for a 12-month randomized trial. Alzheimers Dement. 2025 Apr;21(4):e70219. doi: 10.1002/alz.70219.
- Individual participant dataSharing planned: No
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Down Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diet and Health Education in people with Down Syndrome and Alzheimer Disease, run by University of Kansas Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lauren Ptomey, PhD (913-588-7982, lptomey@kumc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma Amyloid beta 42:40 ratio (time frame: Baseline, 6, 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05985486, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2026.