Last updated: November 3, 2020
Sponsor: University Hospital, Tours
Overall Status: Completed
Phase
3
Condition
Memory Loss
Aging
Mental Disability
Treatment
N/AClinical Study ID
NCT02185222
SERC12-TC / D-COG
2013-005110-36
Ages > 60 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 forsociocultural level of the patient (GRECO standards for elderly patients),
- Having visual, hearing abilities (authorized equipment) and an oral or writtenexpression 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
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 nervoussystem (blood pressure, higher or equal to 180/100 mmHg, chronic pulmonary diseasewith hypoxia; cerebrovascular accident of less than 3 months, cranial traumatism withpersistent neurologic deficit, subdural hematoma, brain surgery),
- Antecedent of alcoholism or chronic drug-addiction with an obvious or documentedconsequence 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 CognitiveImpairment) of less than 6 months is not a criterion of non-inclusion.
Study Design
Total Participants: 68
Study Start date:
October 23, 2014
Estimated Completion Date:
October 10, 2018
Connect with a study center
Chu Angers
Angers, 49933
FranceSite Not Available
CH BLOIS
Blois,
FranceSite Not Available
CHU BREST - Hôpital de la Cavale Blanche
Brest, 29200
FranceSite Not Available
CHI ELBEUF Louviers Val-de-Reuil
Elbeuf,
FranceSite Not Available
CHU NANTES - Hôpital Bellier
Nantes, 44093
FranceSite Not Available
CHU NANTES - Hôpital Laënnec
Nantes, 44093
FranceSite Not Available
Chr Orleans
Orléans, 45067
FranceSite Not Available
CHU POITIERS - Hôpital de la Milétrie
Poitiers, 86021
FranceSite Not Available
CHU RENNES - Hôpital Hôtel Dieu
Rennes, 35064
FranceSite Not Available
CHU ROUEN - Hôpital Charles Nicolle
Rouen, 76031
FranceSite Not Available
CHRU TOURS - Hôpital Bretonneau
Tours, 37044
FranceSite Not Available
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