Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001933
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
1999-11-03
Brief Title:
Nefiracetam in the Treatment of Alzheimers Disease
Sponsor:
National Institute of Neurological Disorders and Stroke NINDS
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Nefiracetam Therapy of Alzheimers Type Dementia
Status:
COMPLETED
Status Verified Date:
2002-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Some of the thinking difficulties of Alzheimers patients may be due to a deficiency in a brain chemical called acetylcholine which helps transmit messages between nerve cells Nefiracetam is a new drug that stimulates acetylcholine This study will test whether Nefiracetam can safely improve memory thinking and activities of daily living in patients with mild to moderate intellectual impairment due to Alzheimers disease
Patients in the study must have a caregiver and designated representative Candidates will be given a medical history and physical examination that includes a complete neurologic and neuropsychologic evaluation blood tests and an electrocardiogram A chest X ray and magnetic resonance imaging MRI test will be done on patients who have not had these tests within the previous two years During the 20-week study each patient will take three pills twice a day for twenty weeks of either Nefiracetame or placebo sugar pill Neither the patients nor the doctors will know which patients are getting the drug and which are getting the placebo Blood and urine tests will be done frequently throughout the study Patients will be asked to have a spinal tap on a voluntary basis to measure the levels of drug in the spinal fluid and a PET scan a brain imaging test
At the end of the study patients who feel they are doing well with no side effects from the drug or placebo may be given the option of continuing treatment for another seven months
Animal studies showed that Nefiracetam improved learning impairment and memory in rats with dementia In a small study of humans about one-fourth of patients who were given a low dose of the drug had improved intellectual function and about one-half who received a higher dose improved
Patients in the study must have a caregiver and designated representative Candidates will be given a medical history and physical examination that includes a complete neurologic and neuropsychologic evaluation blood tests and an electrocardiogram A chest X ray and magnetic resonance imaging MRI test will be done on patients who have not had these tests within the previous two years During the 20-week study each patient will take three pills twice a day for twenty weeks of either Nefiracetame or placebo sugar pill Neither the patients nor the doctors will know which patients are getting the drug and which are getting the placebo Blood and urine tests will be done frequently throughout the study Patients will be asked to have a spinal tap on a voluntary basis to measure the levels of drug in the spinal fluid and a PET scan a brain imaging test
At the end of the study patients who feel they are doing well with no side effects from the drug or placebo may be given the option of continuing treatment for another seven months
Animal studies showed that Nefiracetam improved learning impairment and memory in rats with dementia In a small study of humans about one-fourth of patients who were given a low dose of the drug had improved intellectual function and about one-half who received a higher dose improved
Detailed Description:
Diminished cholinergic function has long been implicated in the pathophysiology of Alzheimer type dementia Studies in animal models of this disorder as well as in patients with Alzheimers disease AD suggest that drugs capable of activating central cholinergic transmission can improve cognitive function Nevertheless no currently available drug of this or any other type consistently confers clinically significant benefit To further evaluate the cholinergic hypothesis for symptom palliation with a mechanistically novel pharmacologic tool the acute safety and antidementia efficacy of nefiracetam will be studied using a double-blind placebo-controlled parallel groups design In contrast to the currently available cholinesterase inhibitors nefiracetam enhances the activity of nicotinic acetylcholine receptors by interacting with a protein kinase C pathway and accelerates acetylcholine turnover and release Efficacy in patients with mild to moderate dementia will be assessed through application of standardized neuropsychological test instruments in this first double-blind randomized controlled trial of nefiracetam in AD Safety will be monitored by means of frequent clinical evaluations and laboratory tests
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 99-N-0139 | None | None | None |