Subacute DeliriumNCT05066503
Nutritional Therapy for Delirium in Elderly Hospitalized Subjects
A study testing 260279 active study product in people with Subacute Delirium, run by University of Arkansas at 1 site in United States.
Trial summary
The investigators have developed a proprietary blend of amino acids that they think will help to prevent or reduce the severity of delirium in older adults (60 years and older) who are hospitalized for certain infections. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Subacute Delirium
- What is being tested?
- 260279 active study product
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Nov 2020to Jan 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 60 years and older.
- Documented presence of either delirium, acute confusion, or altered mental status in medical record.
- Currently hospitalized with a diagnosis of one of the following:
- sepsis/septicemia
- Pneumonia
- Urinary tract infection
Show all 17Show fewer
- Clostridium-difficile infection
- Other bone or tissue infection
- Fever of unknown origin
- Aged 60 years and older.
- Current diagnosis of one of the following:
- sepsis/septicemia
- Pneumonia
- Urinary tract infection
- Clostridium-difficile infection
- Other bone or tissue infection
- Fever of unknown origin
Who cannot join
- Chronic kidney disease (eGFR <30).
- Admitted to the hospital for major psychiatric illness.
- Major psychiatric illness not controlled by medication/treatment.
- Delirium etiology of drug overdose or alcohol withdrawal.
- Major surgery within the past five days.
- Known or suspected Covid-19 positive.
- Continuous feeding tube
Trial locations and contacts
1 site in 1 country.
About this study
The investigators have developed a proprietary blend of amino acids that they think will help to prevent or reduce the severity of delirium in older adults (60 years and older) who are hospitalized for certain infections. In this study, up to 60 people will be enrolled.20 will be asked to drink this blend twice a day for up to 4 days, and 20 will receive standard treatment in the hospital for the same time period. The other 20 subjects will be non-delirious control subjects who do not consume any study products.
Read the detailed description
This will be an interventional pilot study to determine the effectiveness of a specific amino acid supplement developed by the investigators versus standard treatment in mitigating delirium in geriatric patients hospitalized at UAMS for certain infections. Up to 40 delirious and 20 non-delirious subjects (Aged 60 years and older) of any gender or ethnicity will be enrolled (60 subjects maximum). Twenty patients with delirium will be asked to drink this blend twice a day for up to 4 days, and 20 patients with delirium will receive standard treatment in the hospital for the same time period. The other 20 subjects will be non-delirious control subjects who do not consume any study products. All subjects will undergo 2-5 blood draws and 3-7 cognitive assessments while they are admitted to the hospital, depending on study group assignment and discharge date.
- Conditions
- Subacute Delirium
- Being tested
- 260279 active study product
- Medical subject headings
- Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
260279 active study productDietary supplement
Also called there is not a non-proprietary name for this supplement.
The active study product (20g per serving) contains 13.6g of amino acids and natural flavors, citric acid, malic acid, and stevia for flavoring.
| Study group | Role | What they receive |
|---|---|---|
| Delirious subjects receiving active study product | Active comparator | Subjects will ingest an oral amino-acid containing nutritional supplement twice daily for up to 4 days. Receives: Dietary Supplement: 260279 active study product |
| Control group | No intervention | Delirious control group and non-delirious control group who receives standard treatment in the hospital. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in CAM-S (Confusion Assessment Method-Short) and 4 AT score from baseline to day 3 or up to day 4.
CAM-S and 4 AT is a tool to determine and quantify delirium. Subjects in the non-control arms will undergo this test twice each day. The score ranges from 0-7, with lower numbers being better (little to no signs of delirium).
Measured: As determined over an up to 4-day intervention duration.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2021
- Study start16 Nov 2020
- Primary completionSep 2026 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subacute DeliriumStudies of the same condition, open and under way.
- More trials run by University of ArkansasThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Arkansas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gohar Azhar, M.D., Principal investigator, University of Arkansas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05066503
- Sponsor's protocol ID
- 260279
- Status last verified
- Sep 2026
- First submitted
- 23 Sep 2021
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutritional Therapy for Delirium in Elderly Hospitalized Subjects
- ClinicalTrials.gov ID
- NCT05066503
- Acronym / sponsor ID
- 260279
- Conditions
- Subacute Delirium
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of ArkansasUniversity, hospital or other
- Study start
- 16 Nov 2020 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 4 Oct 2021 (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 investigators have developed a proprietary blend of amino acids that they think will help to prevent or reduce the severity of delirium in older adults (60 years and older) who are hospitalized for certain infections. In this study, up to 60 people will be enrolled.20 will be asked to drink this blend twice a day for up to 4 days, and 20 will receive standard treatment in the hospital for the same time period. The other 20 subjects will be non-delirious control subjects who do not consume any study products.
Detailed description
This will be an interventional pilot study to determine the effectiveness of a specific amino acid supplement developed by the investigators versus standard treatment in mitigating delirium in geriatric patients hospitalized at UAMS for certain infections. Up to 40 delirious and 20 non-delirious subjects (Aged 60 years and older) of any gender or ethnicity will be enrolled (60 subjects maximum). Twenty patients with delirium will be asked to drink this blend twice a day for up to 4 days, and 20 patients with delirium will receive standard treatment in the hospital for the same time period. The other 20 subjects will be non-delirious control subjects who do not consume any study products. All subjects will undergo 2-5 blood draws and 3-7 cognitive assessments while they are admitted to the hospital, depending on study group assignment and discharge date.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Delirious subjects receiving active study product | Active comparator | Dietary Supplement: 260279 active study productSubjects will ingest an oral amino-acid containing nutritional supplement twice daily for up to 4 days. |
| Control group | No intervention | –Delirious control group and non-delirious control group who receives standard treatment in the hospital. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Aged 60 years and older.
- Documented presence of either delirium, acute confusion, or altered mental status in medical record.
- Currently hospitalized with a diagnosis of one of the following:
- Aged 60 years and older.
- Current diagnosis of one of the following:
Key exclusion criteria (7 listed)
- Chronic kidney disease (eGFR <30).
- Admitted to the hospital for major psychiatric illness.
- Major psychiatric illness not controlled by medication/treatment.
- Delirium etiology of drug overdose or alcohol withdrawal.
- Major surgery within the past five days.
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 |
|---|---|---|
| 260279 active study productAlso: there is not a non-proprietary name for this supplement.The active study product (20g per serving) contains 13.6g of amino acids and natural flavors, citric acid, malic acid, and stevia for flavoring. | Dietary supplement | Delirious subjects receiving active study product |
Primary outcome
Change in CAM-S (Confusion Assessment Method-Short) and 4 AT score from baseline to day 3 or up to day 4.
Time frame: As determined over an up to 4-day intervention duration.
CAM-S and 4 AT is a tool to determine and quantify delirium. Subjects in the non-control arms will undergo this test twice each day. The score ranges from 0-7, with lower numbers being better (little to no signs of delirium).
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 10 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Subacute Delirium
Recruiting
Computer-assisted Cognitive Stimulation Treatment for Delirium
Delirium
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. This study is not recruiting at the moment.
Gohar Azhar, M.D. principal investigator
University of Arkansas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 260279 active study product in people with Subacute Delirium, run by University of Arkansas 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 17 inclusion and 7 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: under way, not looking for participants, as of the sponsor's last update on 10 Sep 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in CAM-S (Confusion Assessment Method-Short) and 4 AT score from baseline to day 3 or up to day 4. (time frame: As determined over an up to 4-day intervention duration.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Sep 2026.