Alzheimer's Disease Clinical Trial
— MARAEOfficial title:
Alzheimer's Disease and Physiological, Cognitive Function and BDNF Levels of Plasma Adaptation After Exercise Training
| NCT number | NCT02968875 |
| Other study ID # | 15/B/03 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | July 2015 |
| Est. completion date | February 2018 |
| Verified date | May 2018 |
| Source | University Hospital Center of Martinique |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
Alzheimer's disease (AD) is a neurodegenerative disease leading to one of the most common forms of dementia in humans and memory disorder is one of the first symptoms that lead to diagnosis.
| Status | Completed |
| Enrollment | 54 |
| Est. completion date | February 2018 |
| Est. primary completion date | December 2017 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years to 60 Years |
| Eligibility |
Inclusion Criteria: - Alzheimer's disease patients diagnosed by a consultation memory (DSM- IV) - Person with at least 60 years - Person with a score higher than 15 in the Mini Mental State Examination - No one can achieve the pedaling motion - People who do not perform regular physical activity on bike - Nobody has given free and informed consent in writing or obtained from a trusted person or the family environment - People affiliated to a social security Exclusion Criteria: - Patient who refused to provide written consent - Inability to pedal - Recent myocardial necrosis (less than 3 months) - Aortic Stenosis - Uncompensated heart failure - Unstable angina - Ventricular arrythmia - Pulmonary embolism - Coxarthrosis, knee, ankle osteoarthritis - Not affiliated to a social security - Patient already participating in another biomedical research |
| Country | Name | City | State |
|---|---|---|---|
| Martinique | CHU de Martinique | Fort-de-France |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital Center of Martinique |
Martinique,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Measuring the effect of a program of endurance training (ET), on the levels of plasma BDNF. | Up to 4 months | ||
| Secondary | Measuring the effect of training on the psychological performance by using questionnaire MMSE | Up to 4 months | ||
| Secondary | Measuring the effect of training on the psychological performance by using questionnaire: Rey auditory verbal learning test (RAVLT) | Up to 4 months | ||
| Secondary | Measuring the effect of training on the psychological performance by using questionnaire: quality of life (QoL-AD) | Up to 4 months | ||
| Secondary | Stress test | Measuring the effect of training on the physiological performance by determining the maximum power of the effort tolerated | Up to 4 months | |
| Secondary | Stress test | Measuring the effect of training on the physiological performance by determining the grip strength | Up to 4 months | |
| Secondary | Measuring the effect of training on the physiological performance with a walk test of 6 minutes. | Up to 4 months |
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