AD-IDEA

CompletedPhase 3

Alzheimer's Disease - Input of Vitamin D With mEmantine Assay

Evaluation d'Une stratégie thérapeutique d'Association médicamenteuse Pour la Prise en Charge de la Maladie d'Alzheimer et Des Maladies apparentées au Stade modéré

Lead sponsor

University Hospital, Angers

Asset

Memantine

Listed sites

Recruiting sites

Enrollment

actual

Study population

Alzheimer’s disease

Key I/E criteria

•Alzheimer's disease•MMSE 10-20

Primary endpoint

•ADAS-Cog

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study ID2010-024506-35

NCT IDNCT01409694

Timeline

Milestones

Study first posted2011-08-04estimated

Study start2011-09 (month precision)

Primary completion2016-01actual (month precision)

Study completion2016-01actual (month precision)

Last update posted2016-09-22estimated

Assets

Drug assets

Memantine

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age60 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Age ≥ 60 years

•Diagnosis of moderate Alzheimer's disease or related disorders (DSM-IV/NINCDSADRDA) with a score of Mini-Mental State Examination (MMSE) between 10 and 20 inclusively

•To have hypovitaminosis D (i.e., serum 25-hydroxyvitamin D [25OHD]concentration < 30 ng/mL)

•To have no hypercalcemia (defined as serum calcium concentration ≥ 2,65 mmol/L)

•To have given and signed an informed consent form to participate in the trial (or informed consent form obtained from the trusted person or legal representative, as appropriate)

•To be affiliated to French Social Security

Exclusion criteria

•The use of standard antidementia drugs (i.e., anticholinesterasics, memantine, or vasodilatators) in the past 60 days

•Severe hepatic or renal failure

•Severe, unstable or poorly controlled medical conditions at the time of the inclusion

•Other cognitive disorders (untreated dysthyroid, deficiency in vitamin B9 or B12, chronic ongoing ethylism, history of syphilis, stroke, delirium revealed with the Confusion Assessment Method (CAM), severe depressive symptomatology (Geriatric Depression score ≥ 10/15))

•Contra-indications to memantine or vitamin D

•Enrollment in another simultaneous clinical trial

Endpoints (5)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Global cognition

Other (unclassified)

Function / daily living

Global cognition

2 endpoints

Primary/protocol endpoint

Change in cognitive performance

Time frame:This outcome is assessed at baseline, 12 and 24 weeks after inclusion

ADAS-Cog

change from baseline, improvement

Secondary/protocol endpoint

Change in other cognitive scores

Time frame:This outcome is assessed at baseline, 12 and 24 weeks after inclusion

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Function / daily living

1 endpoint

Secondary/protocol endpoint

Change in functional performance

Time frame:This outcome is assessed at baseline, 12 and 24 weeks after inclusion

change from baseline, improvement

Other (unclassified)

2 endpoints

Secondary/protocol endpoint/low confidence

Change in posture and gait

Time frame:This outcome is assessed at baseline, 12 and 24 weeks after inclusion

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Between-group comparison of compliance to treatment and tolerance

Time frame:This outcome is assessed at baseline, 12 and 24 weeks after inclusion

concentration, descriptive

Publications (2)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.