Magnetic Resonance Imaging to Measure Treatment Effects of Doxycycline and Rifampicin in Alzheimer's Disease
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Alzheimer's Disease
- Sponsor
- St. Joseph's Healthcare Hamilton
- Enrollment
- 58
- Locations
- 1
- Primary Endpoint
- Changes in MRI Pre Vs Post Treatment
- Status
- Completed
- Last Updated
- 15 years ago
Overview
Brief Summary
Objectives:
To study the changes in brain structure and function using MRI scans in patients treated for Alzheimer's disease.
Methods:
A pilot study of treating Alzheimer's disease with antibiotics showed some promise that this treatment could delay the deterioration of the mind with this disease. This study is being replicated on a larger scale, providing a more definitive answer to this question. In addition to looking at changes of the mind (through cognitive tests), we would like to use MRI scans in these patients before and after treatment to study the structural changes and the chemical changes in the brain. This would provide a non-invasive look at the bran processes that protect the brain from the effect of Alzheimer's as well as confirming that the disease has been modified with treatment.
Impact:
The novel treatment of Alzheimer's with antibiotics has provided a potential breakthrough in the field. In addition to verifying changes in the brain, MRI scans can observe HOW this process could occur, thus opening doors to other new treatments for Alzheimer's and perhaps even cures.
Investigators
Eligibility Criteria
Inclusion Criteria
- •(DARAD Trial)
- •Male or female aged 50 years or older.
- •Diagnosis of dementia using standardized DSM IV criteria and probable Alzheimer's disease (NINCDS-ADRDA criteria).
- •SMMSE score 14-26 inclusive.
- •Patients who have a consistent caregiver who will accompany them to clinic visits, ensure medication compliance, monitor and report adverse events and sign informed consent for his or her own participation.
- •Sufficient visual, hearing and communication skills to complete standardized testing in English.
- •Patients or their legally acceptable representatives for personal care who sign informed consent.
- •Otherwise healthy on physical examination and screening physical and laboratory testing.
Exclusion Criteria
- •(DARAD Trial)
- •Patients with neurodegenerative diseases such as Lewy Body dementia, Parkinson's disease, Fronto-temporal Dementia, Huntington's Chorea, Down's Syndrome or Creutzfeld Jacob Disease.
- •Cognitive impairment which may be due to any of the following conditions:
- •acute cerebral trauma, subdural hematoma, injuries from chronic trauma like boxing.
- •Hypoxic cerebral damage e.g. post cardiac arrest, postanesthesia etc.
- •Vitamin deficiency like B12 deficiency will be treated and stabilized for one month before patients will be randomized to the study. Patients taking B12 for more than one month can be included in the study.
- •Infections like cerebral abscesses, herpes, neurosyphilis, meningitis or AIDS.
- •Primary or metastatic cerebral neoplasia.
- •Endocrine deficiencies like hypercalcemia, hypothyroidism, hyperparathyroidism, Cushing's syndrome, severe renal failure, poorly controlled diabetes mellitus, pituitary disease, etc.
- •Mental retardation. If a patient has one of these conditions and in the opinion of the investigator this condition has stabilized and is not contributing to the decline in cognition then this patient may be included in the study after the steering committee has reviewed the situation and approved participation.
Outcomes
Primary Outcomes
Changes in MRI Pre Vs Post Treatment
Time Frame: 1 Year
Secondary Outcomes
- Comparison of Normal Controls Vs Alzheimer's Disease using MRI(1 Year)