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Completed

NCT Number: NCT00800709

Memantine and Changes of Biological Markers and Brain PET Imaging in Alzheimer's Disease

In AD, tau protein is abnormally hyperphosphorylated. Significant changes of hyperphosphorylated tau levels in CSF are found in AD patients. It has been shown in vitro that memantine can reverse abnormal hyperphosphorylation of tau in hippocampal neurons of rats. A statistically significant reduction of CSF phosphorylated tau at a preliminary 1-year follow-up was observed, from median 126 (interquartile range 107-153) to 108 (88-133) ng/l (p = 0.018). No statistically significant differences of total tau or Aβ42 were found (Gunnarsson MD, 2007).

FDG-PET has the unique ability to estimate the local cerebral metabolic rate of glucose consumption, thus providing information on the distribution of neuronal death and synapse dysfunction in AD in vivo (Herholz K. 2003). Synaptic dysfunction and loss induce a reduction in neuronal energy demand that results in decreased glucose metabolism. Hypometabolism in AD is thought to reflect loss of synaptic activity and density (Herholz K. 2003; Mielke R, et al. 1998).

Another biological markers such as inflammatory factor and APOEε4 also play a part in the onset of AD (Glodzik-Sobanska L, 2007).

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Key information

Conditions

Alzheimer's Disease Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Frontotemporal Dementia Frontotemporal Lobar Degeneration Mental Disorders Metabolic Diseases Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Nutritional and Metabolic Diseases Proteostasis Deficiencies TDP-43 Proteinopathies Tauopathies

Age range

50 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Department of Psychogeriatrics，Shanghai Mental Health Center

Shanghai, Shanghai Municipality, 200030, China

About this study

  • To investigate the effects of daily dosing of memantine for 24 weeks versus placebo on biological markers of subjects with Alzheimer's disease.
  • To investigate the effects of daily dosing of memantine for 24 weeks versus placebo on 18[F]-FDG-PET of brain in subjects with Alzheimer's disease.
  • To investigate the effects of daily dosing of memantine for 24 weeks versus placebo on cognitive function in subjects with Alzheimer's disease.
  • To investigate the effects of daily dosing of memantine for 24 weeks versus placebo on measures of behavior and activities of daily living of subjects with Alzheimer's disease.
  • To investigate the effects of daily dosing of memantine for 24 weeks versus placebo on short term memory.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Written informed consent
  • Clinical diagnosis of Alzheimer's disease which meet the DSM-IV criteria.
  • Subject has moderate to severe Alzheimer's disease as defined by a MMSE score 4 to 20 inclusive at screening.
  • Hachinski Ischemia Score < 4 at screening.
  • Age ≥50 and ≤90 years.
  • Availability of a responsible and steady caregiver to ensure treatment compliance and provide information for assessments.

Exclusion criteria

  • Severe renal impairment.
  • History of seizures
  • Systolic blood pressure >160 or < 90 mmHg or diastolic blood pressure > 95 or < 60 mmHg at the time of screening.
  • Diagnosis of any concomitant life threatening illness.

Treatment and study plan

Memantine

Drug

Initially memantine 5mg/day, titrated within the first month to a maintenance dose of 20mg/day

Other names: Memantine hydrochloride

Primary outcomes

  1. biological markers of CSF

    Time frame: 24 weeks

  2. 18[F]-FDG-PET of brain

    Time frame: 24 weeks

  3. cognitive function

    Time frame: 24 weeks

Secondary outcomes

  1. behavior and activities of daily living

    Time frame: 24 weeks

  2. short term memory

    Time frame: 24 weeks

Sponsors and collaborators

Lead sponsor

Shanghai Mental Health Center

Other

Collaborators

  • H. Lundbeck A/S

Registry information

Official study title

Changes of Biological Markers and Brain PET Imaging and Clinical Effects of Memantine for Patients With Moderate to Severe Alzheimer's Disease: a 24 Week Double-blind, Randomized, Placebo-Controlled Study

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Dec 2, 2008
Registry last updated
Dec 3, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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