Alzheimer's DiseaseNCT00001977
The Effect of Acetylcholine on Memory and Attention
An observational study of Alzheimer's Disease and Healthy, run by National Institute of Mental Health (NIMH) at 1 site in United States.
Trial summary
This study will examine whether enhancing the chemical acetylcholine in the brain can improve memory and attention. It will identify changes in brain function that occur during these cognitive tasks. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Alzheimer's Disease, Healthy
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2000to Apr 2001
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Three groups of subjects will be enrolled:
Subjects with Alzheimer's Disease (AD) 45-100 years of age;
Healthy controls 20-50 years of age;
Healthy controls 50-90 years of age.
No evidence of, or history of, any medical, neurological or psychiatric condition (other than dementia in the AD patient group) which may affect brain function and metabolism and/or represent a contraindication to the study; including learning disability, psychiatric condition, head trauma with loss of consciousness, seizures or other neurological conditions, alcoholism or substance abuse, hypertension, cardiovascular disease, diabetes and other endocrine diseases, malignancy.
No subjects with vision and/or hearing problems severe enough to interfere with testing.
No females with a positive pregnancy test.
No subjects with contraindications to magnetic resonance imaging (MRI), including pacemakers, cochlear implants, surgical clips or metal fragments in their eyes or body parts.
Only subjects with good health and without evidence of significant chronic disease will be accepted into the healthy control groups.
Only patients without evidence of significant chronic disease who meet standard clinical criteria for the diagnosis of dementia of Alzheimer's disease type will be accepted into the study in the AD group.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institute of Mental Health (NIMH)
Bethesda, Maryland, 20892
About this study
Official title: Cholinergic Modulation of Human Memory and Attention: Functional Neuroimaging Studies
This study will examine whether enhancing the chemical acetylcholine in the brain can improve memory and attention. It will identify changes in brain function that occur during these cognitive tasks. Animal and human studies have shown that a decrease in acetylcholine may be responsible for some of the cognition deficits in Alzheimer's disease. Conversely, patients taking medications that slow the breakdown of this neurotransmitter have experienced improvements in memory.
Normal volunteers and patients with Alzheimer's disease may be eligible for this study of functional brain imaging using positron emission tomography (PET) and magnetic resonance imaging (MRI). These techniques can measure brain activity and identify brain regions involved in memory and attention. Candidates for this study will be screened with a medical and psychiatric history and a physical examination including blood tests, urinalysis, chest X-ray, and electrocardiogram (ECG). Those enrolled will perform memory and attention tasks during PET and MRI studies. The cognition tasks will be repeated twice-once during infusion of saline (a fluid with no drug effect) through a catheter inserted into a blood vessel and again during infusion of physostigmine, a drug that delays the breakdown of acetylcholine. The PET procedure will be completed in one day; the MRI procedure will be done on two different days.
Read more
During imaging, attention and memory tasks will be presented in short blocks of about 4-minutes duration. They will be repeated in sequence up to 10 times with a few minutes separation. Subjects will be shown pictures of faces or other visual stimuli and asked to decide whether the pictures are the same or different.
Information gained from this study may increase knowledge about how acetylcholine affects the brain's response to memory and attention tasks and perhaps lead to better treatments for the cognitive deficits in Alzheimer's disease.
Read the detailed description
The goal of this research project is to determine the role of cholinergic neuromodulation in the functional organization of memory and attention in humans, using functional neuroimaging techniques. The study of human cognition with functional brain imaging in conjunction with pharmacologic probes that alter cognitive processes provides an opportunity to examine another dimension of the organization of human neural systems. In addition to identifying the anatomical structures that participate in specific cognitive functions, this approach can reveal how different neuromodulators can influence processing in those structures. Additionally, the combined use of functional brain imaging and pharmacological manipulation can be used to evaluate the role of neurotransmitter dysfunction in disease states that produce cognitive impairment and may direct us to potential therapeutic approaches.
- Conditions
- Alzheimer's Disease, Healthy
- Keywords
- Alzheimer's Disease, Attention, Brain, Functional Magnetic Resonance Imaging, Physostigmine, Positron Emission Tomography, Working Memory
- Medical subject headings
- Alzheimer Disease
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2002 (estimated)
- Study startJan 2000
- Study completionApr 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Alzheimer's 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
- Observational
- Enrolment
- 70 participants
Sponsor and investigators
- Lead sponsor
- National Institute of Mental Health (NIMH)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00001977
- Sponsor's protocol ID
- 000056
- Other IDs
- 00-M-0056
- Status last verified
- Jan 2000
- First submitted
- 20 Jan 2000
- Last updated
- 4 Mar 2008
- Results posted
- No
Publications
Baddeley AD, Bressi S, Della Sala S, Logie R, Spinnler H. The decline of working memory in Alzheimer's disease. A longitudinal study. Brain. 1991 Dec;114 ( Pt 6):2521-42. doi: 10.1093/brain/114.6.2521.
PubMed 1782529Bajalan AA, Wright CE, van der Vliet VJ. Changes in the human visual evoked potential caused by the anticholinergic agent hyoscine hydrobromide: comparison with results in Alzheimer's disease. J Neurol Neurosurg Psychiatry. 1986 Feb;49(2):175-82. doi: 10.1136/jnnp.49.2.175.
PubMed 3950635
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cholinergic Modulation of Human Memory and Attention: Functional Neuroimaging Studies
- ClinicalTrials.gov ID
- NCT00001977
- Acronym / sponsor ID
- 000056
- Conditions
- Alzheimer's Disease, Healthy
- Keywords
- Alzheimer's Disease, Attention, Brain, Functional Magnetic Resonance Imaging, Physostigmine, Positron Emission Tomography, Working Memory
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants
- Lead sponsor
- National Institute of Mental Health (NIMH)US National Institutes of Health
- Study start
- Jan 2000
- Study completion
- Apr 2001
- First posted
- 10 Dec 2002 (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 examine whether enhancing the chemical acetylcholine in the brain can improve memory and attention. It will identify changes in brain function that occur during these cognitive tasks. Animal and human studies have shown that a decrease in acetylcholine may be responsible for some of the cognition deficits in Alzheimer's disease. Conversely, patients taking medications that slow the breakdown of this neurotransmitter have experienced improvements in memory.
Normal volunteers and patients with Alzheimer's disease may be eligible for this study of functional brain imaging using positron emission tomography (PET) and magnetic resonance imaging (MRI). These techniques can measure brain activity and identify brain regions involved in memory and attention. Candidates for this study will be screened with a medical and psychiatric history and a physical examination including blood tests, urinalysis, chest X-ray, and electrocardiogram (ECG). Those enrolled will perform memory and attention tasks during PET and MRI studies. The cognition tasks will be repeated twice-once during infusion of saline (a fluid with no drug effect) through a catheter inserted into a blood vessel and again during infusion of physostigmine, a drug that delays the breakdown of acetylcholine. The PET procedure will be completed in one day; the MRI procedure will be done on two different days.
During imaging, attention and memory tasks will be presented in short blocks of about 4-minutes duration. They will be repeated in sequence up to 10 times with a few minutes separation. Subjects will be shown pictures of faces or other visual stimuli and asked to decide whether the pictures are the same or different.
Information gained from this study may increase knowledge about how acetylcholine affects the brain's response to memory and attention tasks and perhaps lead to better treatments for the cognitive deficits in Alzheimer's disease.
Detailed description
The goal of this research project is to determine the role of cholinergic neuromodulation in the functional organization of memory and attention in humans, using functional neuroimaging techniques. The study of human cognition with functional brain imaging in conjunction with pharmacologic probes that alter cognitive processes provides an opportunity to examine another dimension of the organization of human neural systems. In addition to identifying the anatomical structures that participate in specific cognitive functions, this approach can reveal how different neuromodulators can influence processing in those structures. Additionally, the combined use of functional brain imaging and pharmacological manipulation can be used to evaluate the role of neurotransmitter dysfunction in disease states that produce cognitive impairment and may direct us to potential therapeutic approaches.
Study design
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
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
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 4 Mar 2008.
- Background: PubMed 1782529Baddeley AD, Bressi S, Della Sala S, Logie R, Spinnler H. The decline of working memory in Alzheimer's disease. A longitudinal study. Brain. 1991 Dec;114 ( Pt 6):2521-42. doi: 10.1093/brain/114.6.2521.
- Background: PubMed 3950635Bajalan AA, Wright CE, van der Vliet VJ. Changes in the human visual evoked potential caused by the anticholinergic agent hyoscine hydrobromide: comparison with results in Alzheimer's disease. J Neurol Neurosurg Psychiatry. 1986 Feb;49(2):175-82. doi: 10.1136/jnnp.49.2.175.
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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 Alzheimer's Disease and Healthy, 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.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2008. 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?
On the ClinicalTrials.gov record for NCT00001977, which also lists 2 linked publications.
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 4 Mar 2008.