Minocycline in Patients With Alzheimer's Disease
Condition: Mild Cognitive Impairment; Alzheimer's Disease
MeSH terms: Alzheimer Disease; Cognitive Dysfunction
Study type: Interventional
Phase: Phase 2

Summary: 
      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 proton (1H ) and carbon 13 (13C)
      magnetic resonance spectroscopy (MRS). Each individual will receive minocycline oral
      administration for 4 weeks initially, after which MRI, MRS and neuropsychological results
      will be recorded. If no adverse side effects occur, subjects will continue minocycline
      administration for an additional 5 months.
    

Detailed description: 
      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.
    

Intervention name(s): Minocycline
Intervention type(s): Drug
Intervention description(s): 50mg, twice daily for 6 months.
Other intervention name(s): Tetracycline
Intervention MeSH terms: Minocycline; Tetracycline
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Magnetic Resonance Imaging; Magnetic Resonance Spectroscopy; Neuroinflammation; Mild Cognitive Impairment; Alzheimer's Disease; Minocycline