Minocycline in Patients With Alzheimer's Disease
Recruitment status was Recruiting
Cognitively normal individuals, patients with Mild Cognitive Impairment (MCI) or Alzheimer's Disease (AD) will undergo clinical screening, neuropsychological tests, blood and urine analyses, quantitative magnetic resonance imaging (MRI) and 1H and 13C magnetic resonance spectroscopy (MRS). Each individual will receive minocycline oral administration for 4 weeks initially, after which MRI, MRS and neuropsych results will be recorded. If no adverse side effects occur, subjects will continue minocycline administration for an additional 5 months.
Mild Cognitive Impairment
Drug: Sugar Pill
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||MRI and MRS Diagnosis and Treatment Monitoring of Alzheimer's Disease With Novel Therapy|
- Changes in brain chemistry and brain volumes over time [ Time Frame: Patients will be monitored for duration of study, up to 6 months. ] [ Designated as safety issue: No ]Using established clinical measures, quantitative magnetic resonance imaging (MRI) and magnetic resonance spectroscopy (MRS), patients will be examined every 4 weeks. Changes in brain chemistry (MRS) concentrations (NAA/Cr and mI/Cr) are measured by amplitude of each peak and compared over 6 months. Changes in brain volumes (MRI), mainly hippocampal (cm3), amygdala (cm3) and lateral ventricular (cm3), will also be measured and charted over the 6 months.
|Study Start Date:||September 2011|
|Estimated Study Completion Date:||November 2012|
|Estimated Primary Completion Date:||October 2012 (Final data collection date for primary outcome measure)|
|Active Comparator: Minocycline||
50mg, twice daily for 6 months.
Other Name: Tetracycline
|Placebo Comparator: Sugar Pill||
Drug: Sugar Pill
Sugar Pill, 50mg twice daily for 6 months.
Other Name: placebo
In the course of on-going trials of novel MRI procedures for Neurological Diagnosis, the investigators have established non-invasive BIOMARKERS (Note: Biomarkers are objective Laboratory tests used in, but not replacing Clinical diagnostic criteria of any disease,in this case age-related dementia of the Alzheimer type and its pre-clinical forms including Mild Cognitive Impairment - MCI) which significantly assist in the Diagnosis of Alzheimer's Disease. MRS, rather like blood tests which are applied for screening and exclusion of medical disorders, provides a pattern of brain chemicals from which this and many other diagnoses have become available (see: Magnetic Resonance Spectroscopy in Neurological Diagnosis: E.R Danielsen and B.D. Ross, Marcel Dekker New York, 1999). Diagnosis of Alzheimer's Disease has hitherto been exclusively a clinical diagnosis, made on the basis of non-specific tests by the treating physician/neurologist. Furthermore, treatments have been of limited efficacy so that the pressure for conclusive diagnosis or an objective characterization of disease progression (or better, regression) has not been a priority. This conservative approach to Alzheimer's Disease changed in 2010 with the Report of National Institutes of Aging. First: The failures of treatment have been ascribed to introduction only in patients with advanced disease ("dementia"). Second: A preliminary form of AD, known as pre-clinical or Mild Cognitive Impairment, has been recognized, distinct from, and generally earlier in the disease course. Third: A new set of diagnostic criteria, which include objective 'biomarkers', from cerebrospinal fluid, genetic and imaging analyzes, has been accepted by the Expert Panel. Finally, Clinical trials of existing and new drugs for Alzheimer's Disease are expected to yield better results if initiated earlier - in the pre-clinical phase - and the outcomes evaluated by the earlier changes in an approved panel of biomarkers.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01463384
|Contact: Thao T Tranfirstname.lastname@example.org|
|Contact: Cherise Charleswellemail@example.com|
|United States, California|
|Huntington Medical Research Institutes||Recruiting|
|Pasadena, California, United States, 91105|
|Principal Investigator:||Brian D Ross||Huntington Medical Research Institutes|