Parkinson DiseaseNCT00004451
Randomized Study of the Effects of Glucose on Cognition in Healthy Young and Elderly People and Parkinson's Disease Patients
A study testing Glucose in people with Parkinson Disease, run by National Institute of Mental Health (NIMH) at 1 site in United States.
Trial summary
This study will determine whether glucose facilitates memory in healthy elderly people and those with Parkinson's disease. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Glucose
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 1998to not given
- Phase
- Interventional
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Three groups of subjects are eligible for this study: Healthy young adults between ages 18 and 30; Healthy elderly adults between ages 60 and 90; AND Anyone diagnosed with Parkinson's disease
Who cannot join
- Prior surgery to remove part of the stomach
- Diabetes, Addison's, or Cushing's diseases
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Virginia
Charlottesville, Virginia, 22908
About this study
This study will determine whether glucose facilitates memory in healthy elderly people and those with Parkinson's disease.
Read the detailed description
Subjects fast for 8 hours before receiving a test to determine their blood glucose levels. Following this test, subjects are randomized to receive either a glucose or saccharin sweetened drink. A series of memory tests and an additional 3 blood glucose level tests are administered approximately 15 minutes later. A minimum of 1 week afterward, the subjects return and receive the alternate sweetener followed by additional memory tests.
- Conditions
- Parkinson Disease
- Being tested
- Glucose
- Keywords
- Parkinson disease, neurologic and psychiatric disorders, rare disease
- Medical subject headings
- Parkinson Disease, Neurologic Manifestations, Mental Disorders, Rare Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GlucoseDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 1999 (estimated)
- Study startMar 1998
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by National Institute of Mental Health (NIMH)The 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
- Treatment
- Allocation
- Randomised
- Masking
- Double blind
- Enrolment
- 120 participants
Sponsor and investigators
- Lead sponsor
- National Institute of Mental Health (NIMH)
- Sponsor type
- US National Institutes of Health
- Collaborators
- University of Virginia
- Investigators
- Carol A. Manning, Study chair, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00004451
- Sponsor's protocol ID
- 199/13548
- Other IDs
- K07MH001197
- Status last verified
- Nov 2005
- First submitted
- 18 Oct 1999
- Last updated
- 1 Dec 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Study of the Effects of Glucose on Cognition in Healthy Young and Elderly People and Parkinson's Disease Patients
- ClinicalTrials.gov ID
- NCT00004451
- Acronym / sponsor ID
- 199/13548
- Conditions
- Parkinson Disease
- Keywords
- Parkinson disease, neurologic and psychiatric disorders, rare disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants
- Lead sponsor
- National Institute of Mental Health (NIMH)US National Institutes of Health
- Collaborators
- University of Virginia
- Study start
- Mar 1998
- First posted
- 19 Oct 1999 (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.
This study will determine whether glucose facilitates memory in healthy elderly people and those with Parkinson's disease.
Detailed description
Subjects fast for 8 hours before receiving a test to determine their blood glucose levels. Following this test, subjects are randomized to receive either a glucose or saccharin sweetened drink. A series of memory tests and an additional 3 blood glucose level tests are administered approximately 15 minutes later. A minimum of 1 week afterward, the subjects return and receive the alternate sweetener followed by additional memory tests.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Three groups of subjects are eligible for this study: Healthy young adults between ages 18 and 30; Healthy elderly adults between ages 60 and 90; AND Anyone diagnosed with Parkinson's disease
Key exclusion criteria (2 listed)
- Prior surgery to remove part of the stomach
- Diabetes, Addison's, or Cushing's diseases
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 |
|---|---|---|
| Glucose | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2005.
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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.
Carol A. Manning study chair
University of Virginia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Glucose in people with Parkinson Disease, run by National Institute of Mental Health (NIMH) 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 1 inclusion and 2 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: finished, as of the sponsor's last update on 1 Dec 2005. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
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 1 Dec 2005.