Magnetic Resonance Spectroscopy Study of Memantine in Alzheimer's Disease - Alzheimer’s Disease & Related Dementias Atlas

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 IDNAM-MD-50

NCT IDNCT00551161

Timeline

Milestones

Study start2007-08 (month precision)

Study first posted2007-10-30estimated

Primary completion2011-12actual (month precision)

Study completion2011-12actual (month precision)

Results first posted2013-12-18estimated

Last update posted2014-01-28estimated

Assets

Drug assets

Memantine

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age50 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Written informed consent must be obtained from either the subject (if they have decisional capacity) or a Legally Authorized Representative (LAR) (as required by state or local law and the IRB), prior to the initiation of any study-specific procedures. (If a subject is unable to fully consent for himself/herself, but has capacity to appoint a research proxy, the legally authorized research proxy will be asked to sign consent, with the subject signing assent.)

•Male or female outpatients at least 50 years of age at Screening.

•If female, the patient must be at least two years postmenopausal or surgically sterile at Screening.

•The patient has a current diagnosis of probable Alzheimer's disease consistent with NINCDS-ADRDA criteria.

•The patient has a knowledgeable and reliable caregiver who will accompany the patient to all clinic visits during the course of the study.

•Mini-Mental State Examination (MMSE) score of at least 15 and not greater than 26 at Screening.

•Ongoing therapy with a stable dose of donepezil, rivastigmine, or galantamine for at least three months at the time of Screening.

•Physical examination, laboratory evaluations, and EKG results at Screening must be normal, or abnormal findings must be judged not clinically significant by the Investigator.

•The patient's MRI scan conducted as part of Screening (Visit 1) must be consistent with a diagnosis of Alzheimer's disease, and must not include any findings that could confound the spectroscopic analysis of subsequent MRIs (e.g., large cortical stroke, tumor, or other space-occupying brain lesions).

•Vision and hearing (hearing aid permissible) must be sufficient for compliance with testing procedures.

•The patient and/or their Legally Authorized Representative, and their caregiver must be able to speak, read, and understand English sufficiently to understand the nature of the study, to provide written informed consent, and to allow completion of all study assessments

Exclusion criteria

•Clinically significant vitamin B12 deficiency at Screening.

•Patients with a modified Hachinski ischemia score greater than 4 at Screening.

•Patients with evidence of clinically significant and active pulmonary, gastrointestinal, renal, hepatic, endocrine, or cardiovascular system disease. Patients with controlled hypertension and right bundle branch block (complete or partial) may be included in the study. Patients with thyroid disease may also be included in the study provided they are euthyroid on treatment. Patients with controlled diabetes may also be included.

•Patients with severe renal impairment (estimated creatinine clearance < 35 mL/min).

•Patients with systolic blood pressure (while sitting) greater then than 180 mm Hg or less then 90 mm Hg, or diastolic blood pressure (while sitting) greater than 100 mm Hg or less than 50 mm Hg at Screening.

•Patients with evidence of other neurological disorders including, but not limited to, stroke, Parkinson's disease, seizure disorder, hydrocephalus, or head injury with loss of consciousness within the past five years at Screening.

•Patients with a current DSM-IV Axis I disorder other than Alzheimer's disease, including schizophrenia or schizoaffective disorder, bipolar disorder, current major depressive episode, psychosis, panic disorder, or post-traumatic stress disorder.

•Patients with dementia complicated by other organic disease.

•Patients who have had a previous brain scan (MRI or CT) with results inconsistent with a diagnosis of probable Alzheimer's disease.

•Patients with an oncological diagnosis (hematological or solid tumor) which is currently being treated, or for which there has been treatment within the year preceding Screening, or for which there is still evidence of active disease. (Note: Patients with local dermatological tumors at such as basal or squamous cell carcinoma may be included.)

•Patients with an object in the head or neck which would invalidate or obstruct the successful completion of an MRI scan, or patients who have other contraindications to MRI, including those with implanted ferromagnetic material or devices such as cardiac pacemakers, deep brain stimulators, cochlear implants, or intraocular metallic shards.

•Patients who are claustrophobic and/or unable to tolerate MRI at Screening, or whom the Investigator believes will not be able to tolerate further scans scheduled during the course of the study.

•Patients with a known or suspected history (within the past 5 years at Screening) of alcoholism or drug abuse.

•Patients who are on an unstable dose of a cholinesterase inhibitor (donepezil, rivastigmine, or galantamine), are currently taking more than one cholinesterase inhibitor at Screening, who are likely to require a change in cholinesterase drug dose during the course of the study, or for whom a cholinesterase inhibitor therapy is contraindicated.

•Patients with a history of severe drug allergy or hypersensitivity, or patients with known hypersensitivity to memantine, amantadine, rimantadine, or lactose.

•Patients who have been previously treated with or have participated in an investigational study of neramexane, memantine, or amantadine.

•Patients previously treated with commercial memantine.

•Patients who have been in an investigational drug study or who have received treatment with an investigational drug within 30 days or 5 half-lives (whichever is longer) of Screening.

•Patients or caregivers who are unwilling or unable to abide by the visit schedule and other requirements of the study.

•Any condition which would make the patient or caregiver unsuitable for the study in the opinion of the Investigator.

Endpoints (2)

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.

Neuroimaging

2 endpoints

Primary/protocol endpoint

Changes in the Metabolite Ratios of N-acetylaspartate (NAA) to Creatine (Cr), Myo-inositol (mI) to Cr, Choline (Cho) to Cr, NAA to Cho, and NAA to mI, on Cholinesterase Monotherapy vs Combination of Memantine and Cholinesterase Inhibitor

Time frame:Baseline, 24 weeks, and 48 weeks

ratio, descriptive

Primary/registry result

Changes in the Metabolite Ratios of N-acetylaspartate (NAA) to Creatine (Cr), Myo-inositol (mI) to Cr, Choline (Cho) to Cr, NAA to Cho, and NAA to mI, on Cholinesterase Monotherapy vs Combination of Memantine and Cholinesterase Inhibitor

Time frame:Baseline, 24 weeks, and 48 weeks

ratio, descriptive

Posted result

Group	Value (mean), ratio (normalized to T2-corrected water	Standard deviation
MemantineChange in NAA [(t2-t1) - (t1-t0)]n=11 Participants	-54	102
Change in Cr [(t2-t1) - (t1-t0)]n=11 Participants	-2	36
Change in Cho [(t2-t1) - (t1-t0)]n=11 Participants	9	12
Change in mI [(t2-t1) - (t1-t0)]n=11 Participants	16	23
Change in NAA/Cr [(t2-t1) - (t1-t0)]n=11 Participants	-0.09	0.15
Change in Cho/Cr [(t2-t1) - (t1-t0)]n=11 Participants	0.02	0.06
Change in mI/Cr [(t2-t1) - (t1-t0)]n=11 Participants	0.04	0.08
Change in NAA/Cho [(t2-t1) - (t1-t0)]n=11 Participants	-0.26	0.39
Change in NAA/mI [(t2-t1) - (t1-t0)]n=11 Participants	-0.35	0.50

p<0.05Wilcoxon (Mann-Whitney)

Publications (21)

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 tableClinicalTrials.gov results section

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.