Phase 3
Completed N=17
The Effect of Memantine on Brain Structure and Chemistry in Alzheimer's Disease Patients
Source: ClinicalTrials.gov NCT00255086 ↗Enrolled (actual)
17
Serious AEs
17.7%
Results posted
Apr 2017
Primary outcomePrimary: NAA/Cr Ratio — 1.47; 1.38; 1.62; 1.41 Ratio
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
The aim of the proposed study is to determine if the NMDA receptor antagonist memantine has a neuroprotective effect on magnetic resonance spectroscopic imaging (MRS) measures of brain NAA and magnetic resonance imaging (MRI) volumetric measures of hippocampal volume. In secondary analyses, we will determine if measures of clinical stabilization produced by memantine in the treatment of Alzheimer's disease (AD) parallels stabilization of MRS measures of brain NAA and MRI volumetric measures of hippocampal volume.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY NAA/Cr Ratio |
1.47; 1.38; 1.62; 1.41 | — |
| SECONDARY Mean Change on the ADAS-Cog Score After 1 Year |
44.67; 49.17; 45.75; 50.39 | — |
Eligibility Criteria
Inclusion Criteria:1. Dementia criteria by DSM-IV.
- 50-95 years of age inclusive.
- MMSE at screen and baseline 7-28 inclusive.
- Conversant in English.
- Caregiver/study partner willing to participate, supervise the patient and be available for administration of study medication.
- Able to ingest oral medication. Exclusion Criteria:1. History of clinically significant stroke without substantial recovery.
- Neurological or medical conditions causing significant disability independent of dementia.
- Parkinson's disease.
- History in past two years of focal brain lesion, head injury with loss of consciousness or DSM-IV criteria for any major psychiatric disorder including psychosis, major depression, bipolar disorder, alcohol or substance abuse.
- Dementia due to Korsakoff's syndrome or infectious diseases such as Creutzfeldt-Jakob disease, herpes, encephalitis, or human immunodeficiency virus.
- Sensory impairment that would prevent subject from participating in or cooperating with the protocol.
- Significant clinical disorder or laboratory finding that renders the subject unsuitable for receiving an investigational drug including: clinically significant or unstable hematologic, hepatic, cardiovascular, pulmonary, gastrointestinal, endocrine, metabolic, renal, or other systemic disease or laboratory abnormality.
- Clinical contraindication to the use of memantine (e.g., hypersensitivity).
- History of seizure within past 5 years prior to screening.
- Platelet count < 100,000/mm3.
- History of claustrophobia
- Presence of metallic implants such as pacemakers, surgical aneurysm clips, or known metal fragments embedded in the body
Data sourced from ClinicalTrials.gov (NCT00255086). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.