The Effect of Acetylcholine on Memory and Attention
|First Received Date ICMJE||January 20, 2000|
|Last Updated Date||March 3, 2008|
|Start Date ICMJE||January 2000|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00001977 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||The Effect of Acetylcholine on Memory and Attention|
|Official Title ICMJE||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.
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.
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 Type ICMJE||Observational|
|Study Design ICMJE||Not Provided|
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Not Provided|
|Study Population||Not Provided|
|Intervention ICMJE||Not Provided|
|Study Group/Cohort (s)||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Completion Date||April 2001|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
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.
|Accepts Healthy Volunteers||Yes|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Location Countries ICMJE||United States|
|NCT Number ICMJE||NCT00001977|
|Other Study ID Numbers ICMJE||000056, 00-M-0056|
|Has Data Monitoring Committee||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||National Institute of Mental Health (NIMH)|
|Collaborators ICMJE||Not Provided|
|Investigators ICMJE||Not Provided|
|Information Provided By||National Institutes of Health Clinical Center (CC)|
|Verification Date||January 2000|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP