Mild and Moderate Alzheimer's DiseaseNCT02249468
An Exploratory Study to Compare the Differences in Nutritional Status Between Patients With Mild and Moderate Alzheimer's Disease (AD) and Cognitively Intact Healthy People in an Asian Population
An observational study of Mild and Moderate Alzheimer's Disease and Cognitively Healthy People, run by Danone Nutricia Research at 1 site in Singapore.
Trial summary
Difference in nutritional status between patients with mild and moderate Alzheimer's Disease (AD) and cognitively intact healthy people in an Asian population Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mild and Moderate Alzheimer's Disease, Cognitively Healthy People
- How many people
- 191 participants
- Where
- 1 siteSingapore
- Study dates
- Oct 2014to Nov 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
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 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with mild and moderate Alzheimer's Disease (AD) and cognitively intact healthy people
Who may be able to join
- Age ≥ 50 years old
- Asian ethnicity
- Group 1: Cognitively intact healthy volunteers defined by Cumulative Illness Rating Scale for Geriatrics rating of ≤ 2 for all categories except for the category "psychiatric illness" which should have a rating of 0 and a CDR of 0 within 1 year prior to the visit.
- OR
- Group 2a: AD patients clinically diagnosed with mild AD (according to the National Institute of Neurological and Communicative Disorders, and Stroke-Alzheimer's Disease and Related Disorders criteria (McKhann et al., 1984)) with Clinical Dementia Rating-1
- OR
- Group 2b: AD patients clinically diagnosed with moderate AD (according to the National Institute of Neurological and Communicative Disorders, and Stroke-Alzheimer's Disease and Related Disorders criteria (McKhann et al., 1984)) with Clinical Dementia Rating-2
- Written informed consent provided according to local regulations.
Who cannot join
- Group 1 only: Current diagnosis of AD or other dementias according to National Institute of Neurological and Communicative Disorders, and Stroke-Alzheimer's Disease and Related Disorders criteria (McKhann et al.,1984 )
- Group 2 only: Change in dose within 2 months prior to visit of AD medication (e.g. donepezil, rivastigmine, galantamine or memantine)
- Group 1 and 2:
- Diagnosis of significant neurological disease (for Groups 2a and 2b: other than AD), including vascular dementia according to National Institute of Neurological and Communicative Disorders, and Stroke-Alzheimer's Disease and Related Disorders criteria, cerebral tumour, Huntington's Disease, Parkinson's Disease, normal pressure hydrocephalus, seizures, major depression, schizophrenia and other entities
- Use of vitamins supplements (only vitamins supplements C and D are allowed) for 3 months prior to the visit
- Use of vitamin B injections
Show all 9Show fewer
- Alcohol or drug abuse as per investigator's judgement
- Investigator's uncertainty about the willingness or ability of the patient to comply with the protocol requirements
- Participation in any other studies involving investigational or marketed products concomitantly or within two weeks prior to entry into the study
Trial locations and contacts
1 site in 1 country.
About this study
Difference in nutritional status between patients with mild and moderate Alzheimer's Disease (AD) and cognitively intact healthy people in an Asian population
Read the detailed description
The main objective of the current Asian nutritional status study is to get more insight into the nutritional status of AD patients in an Asian population in Asia. Plasma levels of several micronutrients and the fatty acid profile will be compared between patients with mild and moderate AD and cognitively intact healthy controls in an Asian population
- Medical subject headings
- Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Mild and Moderate Alzheimer's Disease | Not described | |
| Cognitively intact healthy people | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Uridine
To look at nutritional Status in the blood
Measured: 1 day
Serum Phospholipids and Fatty Acid Profile
Serum Phospholipids, fatty acid profile e.g. docosahexaenoic acid / eicosapentaenoic acid / phosphatidylcholine docosahexaenoic acid
To look at nutritional Status in the blood
Measured: 1 day
Red Blood Cell Phospholipids and fatty acid profile
Red Blood Cell Phospholipids, fatty acid profile e.g. docosahexaenoic acid / eicosapentaenoic acid / phosphatidylcholine docosahexaenoic acid
To look at nutritional Status in the blood
Measured: 1 day
Plasma polar lipid profile
Plasma polar lipid profile including several types of phospholipids and their specific species; and cholesterol-esters
To look at nutritional Status in the blood
Measured: 1 day
Choline
To look at nutritional Status in the blood
Measured: 1 day
Homocysteine
To look at nutritional Status in the blood
Measured: 1 day
Vitamin B6
To look at nutritional Status in the blood
Measured: 1 day
Folate
To look at nutritional Status in the blood
Measured: 1 day
Vitamin B12
To look at nutritional Status in the blood
Measured: 1 day
Selenium
To look at nutritional Status in the blood
Measured: 1 day
Vitamin E
To look at nutritional Status in the blood
Measured: 1 day
Vitamin D
To look at nutritional Status in the blood
Measured: 1 day
HbA1C (haemoglobin A1C )
Other blood parameters
Measured: 1 day
Liver Function - Alanine Aminotransferase and Aspartate Aminotransferase
Other blood parameters
Measured: 1 day
Kidney function - Creatinine
Other blood parameters
Measured: 1 day
Inflammatory marker
C-reactive protein analysed using high sensitive C-reactive protein
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2014 (estimated)
- Study startOct 2014
- Primary completionNov 2016
- Study completionNov 2016
Why it stopped: Stop the study for futility based on recommendation from Independent Data Committee.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild and Moderate Alzheimer's DiseaseStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 191 participants (actual)
Sponsor and investigators
- Lead sponsor
- Danone Nutricia Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02249468
- Sponsor's protocol ID
- Alz.1.C/O/0
- Status last verified
- Mar 2017
- First submitted
- 27 Aug 2014
- Last updated
- 3 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Study to Compare the Differences in Nutritional Status Between Patients With Mild and Moderate Alzheimer's Disease (AD) and Cognitively Intact Healthy People in an Asian Population
- ClinicalTrials.gov ID
- NCT02249468
- Acronym / sponsor ID
- Alz.1.C/O/0
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Stop the study for futility based on recommendation from Independent Data Committee.
- Enrolment
- 191 participants (actual)
- Lead sponsor
- Danone Nutricia ResearchIndustry (pharma, biotech, devices)
- Study start
- Oct 2014 (actual)
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 25 Sep 2014 (estimated)
- 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.
Difference in nutritional status between patients with mild and moderate Alzheimer's Disease (AD) and cognitively intact healthy people in an Asian population
Detailed description
The main objective of the current Asian nutritional status study is to get more insight into the nutritional status of AD patients in an Asian population in Asia. Plasma levels of several micronutrients and the fatty acid profile will be compared between patients with mild and moderate AD and cognitively intact healthy controls in an Asian population
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mild and Moderate Alzheimer's Disease | – | – |
| Cognitively intact healthy people | – | – |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with mild and moderate Alzheimer's Disease (AD) and cognitively intact healthy people
Key inclusion criteria (8 listed)
- Age ≥ 50 years old
- Asian ethnicity
- Group 1: Cognitively intact healthy volunteers defined by Cumulative Illness Rating Scale for Geriatrics rating of ≤ 2 for all categories except for the category "psychiatric illness" which should have a rating of 0 and a CDR of 0 within 1 year prior to the visit.
- OR
- Group 2a: AD patients clinically diagnosed with mild AD (according to the National Institute of Neurological and Communicative Disorders, and Stroke-Alzheimer's Disease and Related Disorders criteria (McKhann et al., 1984)) with Clinical Dementia Rating-1
Key exclusion criteria (9 listed)
- Group 1 only: Current diagnosis of AD or other dementias according to National Institute of Neurological and Communicative Disorders, and Stroke-Alzheimer's Disease and Related Disorders criteria (McKhann et al.,1984 )
- Group 2 only: Change in dose within 2 months prior to visit of AD medication (e.g. donepezil, rivastigmine, galantamine or memantine)
- Diagnosis of significant neurological disease (for Groups 2a and 2b: other than AD), including vascular dementia according to National Institute of Neurological and Communicative Disorders, and Stroke-Alzheimer's Disease and Related Disorders criteria, cerebral tumour, Huntington's Disease, Parkinson's Disease, normal pressure hydrocephalus, seizures, major depression, schizophrenia and other entities
- Use of vitamins supplements (only vitamins supplements C and D are allowed) for 3 months prior to the visit
- Use of vitamin B injections
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Uridine
Time frame: 1 day
To look at nutritional Status in the blood
Serum Phospholipids and Fatty Acid Profile
Time frame: 1 day
Serum Phospholipids, fatty acid profile e.g. docosahexaenoic acid / eicosapentaenoic acid / phosphatidylcholine docosahexaenoic acid To look at nutritional Status in the blood
Red Blood Cell Phospholipids and fatty acid profile
Time frame: 1 day
Red Blood Cell Phospholipids, fatty acid profile e.g. docosahexaenoic acid / eicosapentaenoic acid / phosphatidylcholine docosahexaenoic acid To look at nutritional Status in the blood
Plasma polar lipid profile
Time frame: 1 day
Plasma polar lipid profile including several types of phospholipids and their specific species; and cholesterol-esters To look at nutritional Status in the blood
Choline
Time frame: 1 day
To look at nutritional Status in the blood
Homocysteine
Time frame: 1 day
To look at nutritional Status in the blood
Vitamin B6
Time frame: 1 day
To look at nutritional Status in the blood
Folate
Time frame: 1 day
To look at nutritional Status in the blood
Vitamin B12
Time frame: 1 day
To look at nutritional Status in the blood
Selenium
Time frame: 1 day
To look at nutritional Status in the blood
Vitamin E
Time frame: 1 day
To look at nutritional Status in the blood
Vitamin D
Time frame: 1 day
To look at nutritional Status in the blood
HbA1C (haemoglobin A1C )
Time frame: 1 day
Other blood parameters
Liver Function - Alanine Aminotransferase and Aspartate Aminotransferase
Time frame: 1 day
Other blood parameters
Kidney function - Creatinine
Time frame: 1 day
Other blood parameters
Inflammatory marker
Time frame: 1 day
C-reactive protein analysed using high sensitive C-reactive protein
Results and safety
The study was stopped early (reason given: Stop the study for futility based on recommendation from Independent Data Committee.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mild and Moderate Alzheimer's Disease and Cognitively Healthy People, run by Danone Nutricia Research at 1 site in Singapore.
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 8 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: stopped early, as of the sponsor's last update on 3 Mar 2017. 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 Singapore. 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?
The study was stopped early (reason given: Stop the study for futility based on recommendation from Independent Data Committee.). Results are not available in the source record.
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?
Uridine (time frame: 1 day). The study lists 16 primary outcomes in all. 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 3 Mar 2017.