Minocycline in Patients With Alzheimer's Disease

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2012 by Huntington Medical Research Institutes.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Brian D. Ross, MD, Huntington Medical Research Institutes
ClinicalTrials.gov Identifier:
NCT01463384
First received: October 25, 2011
Last updated: January 30, 2012
Last verified: January 2012
  Purpose

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.


Condition Intervention Phase
Mild Cognitive Impairment
Alzheimer's Disease
Drug: Minocycline
Drug: Sugar Pill
Phase 2

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Huntington Medical Research Institutes:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 120
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)
Arms Assigned Interventions
Active Comparator: Minocycline Drug: 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

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.

  Eligibility

Ages Eligible for Study:   55 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Cognitively normal elderly subjects between the ages of 55-90 and patients aged 55 - 90 years who have mild cognitive impairment (MCI) or clinically defined Alzheimer's disease.

Exclusion Criteria:

  • Any person with medical devices such as cardiac pacemakers/defibrillators or neuro-implants as they are contra-indications for MRI/MRS exam.
  • Since the effects of MRI are unknown to the fetus or unborn child, any person who is or may be pregnant will be excluded from the study.
  • History of known allergy or intolerance to minocycline or any other tetracycline
  • Impaired renal function (plasma Creatinine or BUN at recruitment exceeds twice normal upper limit for HMH Laboratory), which can result in higher serum levels of tetracycline, azotemia, hyperphosphatemia and acidosis.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01463384

Contacts
Contact: Thao T Tran 6263975840 thaotran@hmri.org
Contact: Cherise Charleswell 6263975840 ccharleswell.hmri@gmail.com

Locations
United States, California
Huntington Medical Research Institutes Recruiting
Pasadena, California, United States, 91105
Sponsors and Collaborators
Huntington Medical Research Institutes
Investigators
Principal Investigator: Brian D Ross Huntington Medical Research Institutes
  More Information

Additional Information:
No publications provided

Responsible Party: Brian D. Ross, MD, Director, MR Unit, Huntington Medical Research Institutes
ClinicalTrials.gov Identifier: NCT01463384     History of Changes
Other Study ID Numbers: LKW-AB34
Study First Received: October 25, 2011
Last Updated: January 30, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Huntington Medical Research Institutes:
Magnetic Resonance Imaging
Magnetic Resonance Spectroscopy
Neuroinflammation
Mild Cognitive Impairment
Alzheimer's Disease
Minocycline

Additional relevant MeSH terms:
Alzheimer Disease
Mild Cognitive Impairment
Cognition Disorders
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Minocycline
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 22, 2014