Memory Disorders Clinical Trial
— D-COGOfficial title:
Effect of Vitamin D on Cognitive Decline of Patients With Memory Complaint
Verified date | November 2020 |
Source | University Hospital, Tours |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
As recommended allowance of oral vitamine D are unable to ensure the recommended serum concentration of vitamine D, the purpose of this study is to show that a dose of vitamin D3 higher than the recommended allowance may slow the cognitive decline of patients with a memory complaint.
Status | Completed |
Enrollment | 68 |
Est. completion date | October 10, 2018 |
Est. primary completion date | October 10, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 60 Years and older |
Eligibility | Pre-Inclusion Criteria : - Patients aged 60 years or older, - Who report to a memory centre with symptoms of memory complaint, - Having a Mini-Mental State Examination (MMSE) score strictly > the 5th percentile for sociocultural level of the patient (GRECO standards for elderly patients), - Having visual, hearing abilities (authorized equipment) and an oral or written expression sufficient for the suitable realization of the tests, - Who accept participation in the study and are able to sign the informed consent of the - Affiliated to the French social security system. Inclusion Criteria: - Insufficient 25 OH D serum level : 25 OH D < 50 nmol/L (20 ng/ml), - Normal corrected plasma calcium concentration, - Normal kidney function (cockcroft > 30 mL/mn) Exclusion Criteria: - Alzheimer's disease or other dementia, - Parkinson's disease treated, - Epilepsy treated, - Huntington's disease, - Brain tumor, - History of a progressive disease which may have consequences for the central nervous system (blood pressure, higher or equal to 180/100 mmHg, chronic pulmonary disease with hypoxia; cerebrovascular accident of less than 3 months, cranial traumatism with persistent neurologic deficit, subdural hematoma, brain surgery), - Antecedent of alcoholism or chronic drug-addiction with an obvious or documented consequence on cognition, - Severe depression : score Montgomery Asberg Depression Rating Scale (MADRS) > 18, - Psychotropic drug therapy (at the discretion of the clinician), - Hypercalcaemia or treatment for a hypercalcaemia, - Known hypersensitivity to the vitamin D, - Granulomatous disease, - Treatment of vit D at doses higher than the current recommendations, - History of calcium urinary lithiasis of less than 1 year, - Nonsteroidal antiinflammatory drug (NSAID) chronic treatment, - Severe medical or surgical affection of less than 3 months, - Unstable health, severe hepatic or renal deficiency, - Deprivation of liberty, under judicial protection, - Institutionalization (EHPAD), - Illiteracy, - Participation in another biomedical research. A diagnosis of MCI (Mild Cognitive Impairment) of less than 6 months is not a criterion of non-inclusion. |
Country | Name | City | State |
---|---|---|---|
France | Chu Angers | Angers | |
France | CH BLOIS | Blois | |
France | CHU BREST - Hôpital de la Cavale Blanche | Brest | |
France | CHI ELBEUF Louviers Val-de-Reuil | Elbeuf | |
France | CHU NANTES - Hôpital Bellier | Nantes | |
France | CHU NANTES - Hôpital Laënnec | Nantes | |
France | Chr Orleans | Orléans | |
France | CHU POITIERS - Hôpital de la Milétrie | Poitiers | |
France | CHU RENNES - Hôpital Hôtel Dieu | Rennes | |
France | CHU ROUEN - Hôpital Charles Nicolle | Rouen | |
France | CHRU TOURS - Hôpital Bretonneau | Tours |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Tours |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Changes from baseline memory functions measured by the score of the total recall test from Free and Cued Selective Recall Reminding Test (Rappel Libre / Rappel Indicé 16 items : RL/RI 16) at one year and at two years | The score of the total recall test from Free and Cued Selective Recall Reminding Test (RL/RI 16) is recommended by a European Task Force consensus. | Baseline (at inclusion), one year and two years | |
Secondary | Changes from baseline global efficiency measured by the Mc Nair scale at one year and at two years | Baseline (inclusion), one year and two years | ||
Secondary | Evolution of anaemia evaluated by red blood cells count | Baseline (pre-inclusion), one year and two years | ||
Secondary | Evolution of plasma calcium and albumin concentration | Baseline (pre-inclusion), 45 days, one year and two years | ||
Secondary | Evolution of urinary calcium and creatinine concentration | 45 days, one year and two years | ||
Secondary | All adverse events | Up to two years | ||
Secondary | Serum level of 25-hydroxy vitamine D (25-OH D) measured to study observance | Baseline (pre-inclusion), one year and two years | ||
Secondary | Changes from baseline global efficiency measured by the Mini Mental State Examination at one year and at two years | Baseline (at inclusion), one year and two years | ||
Secondary | Changes from baseline global efficiency measured by the Montreal Cognitive Assessment at one year and at two years | Baseline (at inclusion), one year and two years | ||
Secondary | Changes from baseline instrumental activity of daily living measured by 8 items at one year and at two years | Baseline (at inclusion), one year and two years | ||
Secondary | Changes from baseline language measured by the "test de denomination orale d'images" (DO-80) at one year and at two years | Baseline (at inclusion), one year and two years | ||
Secondary | Memory function measured by a visual test : delayed matching to sample 48 items (DMS-48) | Baseline at inclusion | ||
Secondary | Changes from baseline executive functions measured by the stroop test at one year and at two years | Baseline (at inclusion), one year and two years | ||
Secondary | Changes from baseline executive functions measured by the verbal fluency at one year and at two years | Baseline (at inclusion), one year and two years | ||
Secondary | Changes from baseline executive functions measured by the Trail Making Test part B at one year and at two years | Baseline (at inclusion), one year and two years | ||
Secondary | Changes from baseline attention and speed processing measured by the Trail Making Test part A at one year and at two years | Baseline (at inclusion), one year and two years | ||
Secondary | Changes from baseline attention and speed processing measured by the Digit symbol test at one year and at two years | Baseline (at inclusion), one year and two years | ||
Secondary | Changes from baseline visuospatial study measured by the Rey figure (copy) at one year and at two years | Baseline (at inclusion), one year and two years | ||
Secondary | Changes from baseline praxis at one year and at two years | Production of symbolic gesture, imitation utilization gesture, non sense gesture imitation | Baseline (at inclusion), one year and two years | |
Secondary | Changes from baseline depressive symptoms measured by the Montgomery and Asberg Depression Rating Scale at one year and at two years | Baseline (at inclusion), one year and two years |
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