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Trial record 61 of 201 for:    TETRACYCLINE

Minocycline in Patients With Alzheimer's Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01463384
Recruitment Status : Completed
First Posted : November 1, 2011
Results First Posted : September 25, 2014
Last Update Posted : September 25, 2014
Sponsor:
Information provided by (Responsible Party):
Brian D. Ross, MD, Huntington Medical Research Institutes

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Mild Cognitive Impairment
Alzheimer's Disease
Intervention Drug: Minocycline
Enrollment 13
Recruitment Details Patients were recruited from local physicians, through Clinical Trials website and the AD association.
Pre-assignment Details  
Arm/Group Title Minocycline
Hide Arm/Group Description Subjects were administered 50mg minocycline twice daily for 6 months
Period Title: Overall Study
Started 13
Completed 13
Not Completed 0
Arm/Group Title Minocycline
Hide Arm/Group Description Subjects administered 50mg minocycline twice daily for 6 months
Overall Number of Baseline Participants 13
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants
<=18 years
0
   0.0%
Between 18 and 65 years
4
  30.8%
>=65 years
9
  69.2%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 13 participants
73.5  (8.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants
Female
5
  38.5%
Male
8
  61.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 13 participants
13
1.Primary Outcome
Title Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
Hide Description

RBANS is a brief neurocognitive battery with four alternate forms, measuring immediate and delayed memory, attention, language, and visuospatial skills. RBANS was developed as a stand-alone "core" battery for the detection and neurocognitive characterization of dementia and as a brief neurocognitive battery for the detection and tracking of neurocognitive deficits in a variety of disorders. (Reference: http://rbans.com/)

Qualitative Description of Index Scores:

Index Score Classification 130 and above Very Superior 120-129 Superior 110-119 High Average 90-109 Average 80-89 Low Average 70-79 Borderline 69 and below Extremely Low

Psychometric range for RBANS:

AD 0 - 77 MCI 78 - 99 Normal > 100

Range of scores: Minimum = 0, Maximum = 130

Values are reported below for Baseline, averaged for 1-3 months, and averaged for 4-6 months during minocycline administration.

Time Frame Baseline values, 1-3 Months Values (averaged), 4-6 Months Values (averaged)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Minocycline AD Minocycline MCI Minocycline NC
Hide Arm/Group Description:
Alzheimer subjects who were administered 50mg minocycline twice daily.
Mild cognitively impaired subject who was administered 50mg minocycline twice daily.
Normal control subjects who were administered 50mg minocycline twice daily.
Overall Number of Participants Analyzed 4 1 8
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline Values 49  (8) 81 106  (13)
Averaged Values for Months 1-3 32.5  (3.4) 58.7 108.4  (26)
Averaged Values for Months 4-6 32.9  (4.2) 63.8 123.6  (37.1)
2.Primary Outcome
Title Hippocampal Volumes Measured in Three Groups: Alzheimer Disease (AD), Mild Cognitive Impairment (MCI) and Normal, Age-matched Controls (NC).
Hide Description

Using magnetic resonance images acquired, hippocampal volume was measured monthly for 6 months.

Normal range for hippocampal volume in aged-matched controls is 6.6 - 8.8 cm^3.

Values are reported below for Baseline, averaged for 1-3 months, and averaged for 4-6 months during minocycline administration.

Time Frame Baseline values, 1-3 Months Values (averaged), 4-6 Months Values (averaged)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Minocycline AD Minocycline MCI Minocycline NC
Hide Arm/Group Description:
Alzheimer subjects who were administered 50mg minocycline twice daily.
Mild cognitively impaired subject who was administered 50mg minocycline twice daily.
Normal control subjects who were administered 50mg minocycline twice daily.
Overall Number of Participants Analyzed 4 1 8
Mean (Standard Deviation)
Unit of Measure: cm^3
Baseline Values 5.49  (1.14) 6.35 6.98  (1.18)
Averaged Values for Months 1-3 5.42  (1.06) 6.30 6.92  (0.48)
Averaged Values for Months 4-6 4.94  (1.2) 7.60 6.82  (0.45)
3.Primary Outcome
Title Biomarker NAA/mI Measured in Three Groups: Alzheimer Disease (AD), Mild Cognitive Impairment (MCI) and Normal, Age-matched Controls (NC)
Hide Description

It has been demonstrated in numerous studies over the past decade that magnetic resonance spectroscopy (MRS) can be used for the diagnosis of Alzheimer's disease. By measuring an area within the posterior cingulate gyrus, one can obtain a biochemical signature of that region in AD whereby NAA is reduced and mI is increased.

These two biomarkers, N-acetylaspartate (NAA, a neuronal marker) and myo-inositol (mI, a glial marker) were quantified and then used to calculate NAA/mI (an index currently widely used for AD and MCI diagnosis).

Scale of MRS biomarkers for aged-matched controls: NAA = 1.43, mI = 0.60, NAA/mI = 2.38. Any value lower than NAA/mI of 2.38 are considered not normal.

Values are reported below for Baseline, averaged for 1-3 months, and averaged for 4-6 months during minocycline administration.

Time Frame Baseline values, 1-3 Months Values (averaged), 4-6 Months Values (averaged)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Minocycline AD Minocycline MCI Minocycline NC
Hide Arm/Group Description:
Alzheimer subjects who were administered 50mg minocycline twice daily.
Mild cognitively impaired subject who was administered 50mg minocycline twice daily.
Normal control subjects who were administered 50mg minocycline twice daily.
Overall Number of Participants Analyzed 4 1 8
Mean (Standard Deviation)
Unit of Measure: Ratio
Baseline Values 1.69  (0.38) 1.87 2.42  (0.08)
Averaged Values for Months 1-3 1.78  (0.61) 1.80 2.44  (0.26)
Averaged Values for Months 4-6 1.84  (0.61) 2.08 2.47  (0.41)
Time Frame 7 months
Adverse Event Reporting Description No adverse events were reported.
 
Arm/Group Title Minocycline
Hide Arm/Group Description No adverse events were reported in any subjects who were taking minocycline. All subjects underwent monthly blood tests to monitor alanine transaminase and blood urea nitrogen levels.
All-Cause Mortality
Minocycline
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
Minocycline
Affected / at Risk (%)
Total   0/13 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Minocycline
Affected / at Risk (%)
Total   0/13 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Principal Investigator
Organization: Huntington Medical Research Institutes
Phone: 6263975840
EMail: mrs@hmri.org
Layout table for additonal information
Responsible Party: Brian D. Ross, MD, Huntington Medical Research Institutes
ClinicalTrials.gov Identifier: NCT01463384    
Other Study ID Numbers: LKW-AB34
First Submitted: October 25, 2011
First Posted: November 1, 2011
Results First Submitted: October 25, 2012
Results First Posted: September 25, 2014
Last Update Posted: September 25, 2014