Trial Outcomes & Findings for Minocycline in Patients With Alzheimer's Disease (NCT NCT01463384)
NCT ID: NCT01463384
Last Updated: 2014-09-25
Results Overview
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.
COMPLETED
PHASE2
13 participants
Baseline values, 1-3 Months Values (averaged), 4-6 Months Values (averaged)
2014-09-25
Participant Flow
Patients were recruited from local physicians, through Clinical Trials website and the AD association.
Participant milestones
| Measure |
Minocycline
Subjects were administered 50mg minocycline twice daily for 6 months
|
|---|---|
|
Overall Study
STARTED
|
13
|
|
Overall Study
COMPLETED
|
13
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Minocycline in Patients With Alzheimer's Disease
Baseline characteristics by cohort
| Measure |
Minocycline
n=13 Participants
Subjects administered 50mg minocycline twice daily for 6 months
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
9 Participants
n=93 Participants
|
|
Age, Continuous
|
73.5 years
STANDARD_DEVIATION 8.8 • n=93 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
13 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: Baseline values, 1-3 Months Values (averaged), 4-6 Months Values (averaged)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.
Outcome measures
| Measure |
Minocycline AD
n=4 Participants
Alzheimer subjects who were administered 50mg minocycline twice daily.
|
Minocycline MCI
n=1 Participants
Mild cognitively impaired subject who was administered 50mg minocycline twice daily.
|
Minocycline NC
n=8 Participants
Normal control subjects who were administered 50mg minocycline twice daily.
|
|---|---|---|---|
|
Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
Baseline Values
|
49 units on a scale
Standard Deviation 8
|
81 units on a scale
|
106 units on a scale
Standard Deviation 13
|
|
Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
Averaged Values for Months 1-3
|
32.5 units on a scale
Standard Deviation 3.4
|
58.7 units on a scale
|
108.4 units on a scale
Standard Deviation 26
|
|
Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
Averaged Values for Months 4-6
|
32.9 units on a scale
Standard Deviation 4.2
|
63.8 units on a scale
|
123.6 units on a scale
Standard Deviation 37.1
|
PRIMARY outcome
Timeframe: Baseline values, 1-3 Months Values (averaged), 4-6 Months Values (averaged)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.
Outcome measures
| Measure |
Minocycline AD
n=4 Participants
Alzheimer subjects who were administered 50mg minocycline twice daily.
|
Minocycline MCI
n=1 Participants
Mild cognitively impaired subject who was administered 50mg minocycline twice daily.
|
Minocycline NC
n=8 Participants
Normal control subjects who were administered 50mg minocycline twice daily.
|
|---|---|---|---|
|
Hippocampal Volumes Measured in Three Groups: Alzheimer Disease (AD), Mild Cognitive Impairment (MCI) and Normal, Age-matched Controls (NC).
Baseline Values
|
5.49 cm^3
Standard Deviation 1.14
|
6.35 cm^3
|
6.98 cm^3
Standard Deviation 1.18
|
|
Hippocampal Volumes Measured in Three Groups: Alzheimer Disease (AD), Mild Cognitive Impairment (MCI) and Normal, Age-matched Controls (NC).
Averaged Values for Months 1-3
|
5.42 cm^3
Standard Deviation 1.06
|
6.30 cm^3
|
6.92 cm^3
Standard Deviation 0.48
|
|
Hippocampal Volumes Measured in Three Groups: Alzheimer Disease (AD), Mild Cognitive Impairment (MCI) and Normal, Age-matched Controls (NC).
Averaged Values for Months 4-6
|
4.94 cm^3
Standard Deviation 1.2
|
7.60 cm^3
|
6.82 cm^3
Standard Deviation 0.45
|
PRIMARY outcome
Timeframe: Baseline values, 1-3 Months Values (averaged), 4-6 Months Values (averaged)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.
Outcome measures
| Measure |
Minocycline AD
n=4 Participants
Alzheimer subjects who were administered 50mg minocycline twice daily.
|
Minocycline MCI
n=1 Participants
Mild cognitively impaired subject who was administered 50mg minocycline twice daily.
|
Minocycline NC
n=8 Participants
Normal control subjects who were administered 50mg minocycline twice daily.
|
|---|---|---|---|
|
Biomarker NAA/mI Measured in Three Groups: Alzheimer Disease (AD), Mild Cognitive Impairment (MCI) and Normal, Age-matched Controls (NC)
Baseline Values
|
1.69 Ratio
Standard Deviation 0.38
|
1.87 Ratio
|
2.42 Ratio
Standard Deviation 0.08
|
|
Biomarker NAA/mI Measured in Three Groups: Alzheimer Disease (AD), Mild Cognitive Impairment (MCI) and Normal, Age-matched Controls (NC)
Averaged Values for Months 1-3
|
1.78 Ratio
Standard Deviation 0.61
|
1.80 Ratio
|
2.44 Ratio
Standard Deviation 0.26
|
|
Biomarker NAA/mI Measured in Three Groups: Alzheimer Disease (AD), Mild Cognitive Impairment (MCI) and Normal, Age-matched Controls (NC)
Averaged Values for Months 4-6
|
1.84 Ratio
Standard Deviation 0.61
|
2.08 Ratio
|
2.47 Ratio
Standard Deviation 0.41
|
Adverse Events
Minocycline
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Principal Investigator
Huntington Medical Research Institutes
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place