Phase 2
Completed N=13
Minocycline in Patients With Alzheimer's Disease
Mild Cognitive Impairment · Alzheimer's Disease
Source: ClinicalTrials.gov NCT01463384 ↗
Enrolled (actual)
13
Serious AEs
0.0%
Results posted
Sep 2014
Primary outcomePrimary: Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) — 49; 81; 106; 32.5 units on a scale
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) |
49; 81; 106; 32.5; 58.7; 108.4 | — |
| PRIMARY Hippocampal Volumes Measured in Three Groups: Alzheimer Disease (AD), Mild Cognitive Impairment (MCI) and Normal, Age-matched Controls (NC). |
5.49; 6.35; 6.98; 5.42; 6.30; 6.92 | — |
| PRIMARY Biomarker NAA/mI Measured in Three Groups: Alzheimer Disease (AD), Mild Cognitive Impairment (MCI) and Normal, Age-matched Controls (NC) |
1.69; 1.87; 2.42; 1.78; 1.80; 2.44 | — |
Eligibility 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 blood urea nitrogen (BUN) levels exceeds twice normal upper limit which can result in higher serum levels of tetracycline, azotemia, hyperphosphatemia and acidosis.
Data sourced from ClinicalTrials.gov (NCT01463384). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.