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A Study of the Safety and Efficacy of Memantine in Moderate to Severe Alzheimer's Disease

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00322153
First Posted: May 5, 2006
Last Update Posted: September 16, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Forest Laboratories
Results First Submitted: July 20, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Dementia of the Alzheimer's Type
Interventions: Drug: memantine ER
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The recruitment period was from May 20, 2005 to April 18th, 2007 at 83 study centers in four countries (23 in Argentina, 11 in Chile, 11 in Mexico, and 38 in the US)

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Study consisted of 1-2 weeks single-blind placebo treatment followed by 24 weeks double-blind treatment. At the end of single-blind placebo treatment, patients meeting entry criteria were randomized (1:1) to 1 of 2 double-blind treatment groups receiving memantine or placebo.

Reporting Groups
  Description
Placebo Matching placebo oral administration once daily for 24 weeks.
Memantine ER 28mg once daily oral administration for 24 weeks.

Participant Flow:   Overall Study
    Placebo   Memantine ER
STARTED   335 [1]   342 [2] 
SAFETY POPULATION   335 [3]   341 [4] 
COMPLETED   272   273 
NOT COMPLETED   63   69 
Adverse Event                21                34 
Protocol Violation                6                14 
Withdrawal by Subject                18                10 
Lack of Efficacy                8                3 
Lost to Follow-up                5                4 
Withdrawn for other reasons                5                4 
[1] Randomized to placebo
[2] Randomized to Memantine ER
[3] Safety population defined as all patients who took at least one dose of double-blind study drug.
[4] Safety population: one patient was randomized but did not receive double-blind study drug.



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo Matching placebo oral administration once daily for 24 weeks.
Memantine ER 28mg once daily oral administration for 24 weeks.
Total Total of all reporting groups

Baseline Measures
   Placebo   Memantine ER   Total 
Overall Participants Analyzed 
[Units: Participants]
 335   341   676 
Age, Customized 
[Units: Participants]
     
<= 64 years   26   34   60 
65-74 years   79   85   164 
75-84 years   179   176   355 
>= 85 years   51   46   97 
Age 
[Units: Years]
Mean (Standard Deviation)
 76.8  (7.76)   76.2  (8.35)   76.5  (8.07) 
Gender 
[Units: Participants]
     
Female   243   244   487 
Male   92   97   189 
Region of Enrollment 
[Units: Participants]
     
United States   85   93   178 
Argentina   158   153   311 
Chile   44   46   90 
Mexico   48   49   97 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change From Baseline in Severe Impairment Battery (SIB) at Week 24 (LOCF)   [ Time Frame: Baseline to week 24 ]

2.  Primary:   Clinician’s Interview-Based Impression of Change With Caregiver Input (CIBIC-plus) at Week 24 (LOCF)   [ Time Frame: Week 24 ]

3.  Secondary:   Change From Baseline in the 19-Item Alzheimer’s Disease Cooperative Study-Activities of Daily Living (ADCS-ADL19) Scale at Week 24 (LOCF)   [ Time Frame: Baseline to week 24 ]


  Serious Adverse Events
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Time Frame Occurring on or after the date of the first dose of double-blind study medication and within 30 days of the date of last dose of double-blind study medication.
Additional Description No text entered.

Reporting Groups
  Description
Placebo Matching placebo oral administration once daily for 24 weeks.
Memantine ER 28mg once daily oral administration for 24 weeks.

Serious Adverse Events
    Placebo   Memantine ER
Total, Serious Adverse Events     
# participants affected / at risk   21/335 (6.27%)   28/341 (8.21%) 
Cardiac disorders     
Atrioventricular block complete † 1     
# participants affected / at risk   0/335 (0.00%)   1/341 (0.29%) 
Bradycardia † 1     
# participants affected / at risk   1/335 (0.30%)   1/341 (0.29%) 
Sinus bradycardia † 1     
# participants affected / at risk   0/335 (0.00%)   1/341 (0.29%) 
Cardiac Arrest † 1     
# participants affected / at risk   1/335 (0.30%)   0/341 (0.00%) 
Cardiac Failure Congestive † 1     
# participants affected / at risk   3/335 (0.90%)   0/341 (0.00%) 
Cardio-respiratory arrest † 1     
# participants affected / at risk   2/335 (0.60%)   0/341 (0.00%) 
Myocardial infarction † 1     
# participants affected / at risk   1/335 (0.30%)   0/341 (0.00%) 
Gastrointestinal disorders     
Diarrhoea † 1     
# participants affected / at risk   0/335 (0.00%)   1/341 (0.29%) 
Rectal Prolapse † 1     
# participants affected / at risk   0/335 (0.00%)   1/341 (0.29%) 
Toothache † 1     
# participants affected / at risk   0/335 (0.00%)   1/341 (0.29%) 
Vomiting † 1     
# participants affected / at risk   0/335 (0.00%)   1/341 (0.29%) 
General disorders     
Chest Pain † 1     
# participants affected / at risk   0/335 (0.00%)   1/341 (0.29%) 
General physical health deterioration † 1     
# participants affected / at risk   0/335 (0.00%)   1/341 (0.29%) 
Drowning † 1     
# participants affected / at risk   1/335 (0.30%)   0/341 (0.00%) 
Infections and infestations     
Pneumonia † 1     
# participants affected / at risk   0/335 (0.00%)   2/341 (0.59%) 
Urinary tract infection † 1     
# participants affected / at risk   3/335 (0.90%)   2/341 (0.59%) 
Lobar Pneumonia † 1     
# participants affected / at risk   0/335 (0.00%)   1/341 (0.29%) 
Meningitis bacterial † 1     
# participants affected / at risk   0/335 (0.00%)   1/341 (0.29%) 
Bacteraemia † 1     
# participants affected / at risk   1/335 (0.30%)   0/341 (0.00%) 
Herpes zoster † 1     
# participants affected / at risk   1/335 (0.30%)   0/341 (0.00%) 
Injury, poisoning and procedural complications     
Fall † 1     
# participants affected / at risk   5/335 (1.49%)   2/341 (0.59%) 
Pneumothorax traumatic † 1     
# participants affected / at risk   0/335 (0.00%)   1/341 (0.29%) 
Skin laceration † 1     
# participants affected / at risk   0/335 (0.00%)   1/341 (0.29%) 
Spinal compression fracture † 1     
# participants affected / at risk   0/335 (0.00%)   1/341 (0.29%) 
Head Injury † 1     
# participants affected / at risk   1/335 (0.30%)   0/341 (0.00%) 
Hip fracture † 1     
# participants affected / at risk   3/335 (0.90%)   0/341 (0.00%) 
Traumatic brain injury † 1     
# participants affected / at risk   1/335 (0.30%)   0/341 (0.00%) 
Investigations     
Anticoagulation drug level above therapeutic † 1     
# participants affected / at risk   0/335 (0.00%)   1/341 (0.29%) 
Metabolism and nutrition disorders     
Anorexia † 1     
# participants affected / at risk   0/335 (0.00%)   1/341 (0.29%) 
Hypoglycaemia † 1     
# participants affected / at risk   1/335 (0.30%)   0/341 (0.00%) 
Hypokalaemia † 1     
# participants affected / at risk   1/335 (0.30%)   0/341 (0.00%) 
Musculoskeletal and connective tissue disorders     
Back Pain † 1     
# participants affected / at risk   0/335 (0.00%)   1/341 (0.29%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Cholesteatoma † 1     
# participants affected / at risk   0/335 (0.00%)   1/341 (0.29%) 
Metastatic carcinoma of the bladder † 1     
# participants affected / at risk   0/335 (0.00%)   1/341 (0.29%) 
Renal neoplasm † 1     
# participants affected / at risk   0/335 (0.00%)   1/341 (0.29%) 
Prostate cancer † 1     
# participants affected / at risk   1/335 (0.30%)   0/341 (0.00%) 
Nervous system disorders     
Cerebrovascular accident † 1     
# participants affected / at risk   0/335 (0.00%)   2/341 (0.59%) 
Syncope † 1     
# participants affected / at risk   0/335 (0.00%)   2/341 (0.59%) 
Cerebral haemorrhage † 1     
# participants affected / at risk   1/335 (0.30%)   1/341 (0.29%) 
Dementia Alzheimer's type † 1     
# participants affected / at risk   0/335 (0.00%)   1/341 (0.29%) 
Facial paresis † 1     
# participants affected / at risk   0/335 (0.00%)   1/341 (0.29%) 
Ischaemic stroke † 1     
# participants affected / at risk   1/335 (0.30%)   1/341 (0.29%) 
Myoclonus † 1     
# participants affected / at risk   0/335 (0.00%)   1/341 (0.29%) 
Syncope vasovagal † 1     
# participants affected / at risk   0/335 (0.00%)   1/341 (0.29%) 
Transient ischaemic attack † 1     
# participants affected / at risk   0/335 (0.00%)   1/341 (0.29%) 
Convulsion † 1     
# participants affected / at risk   1/335 (0.30%)   0/341 (0.00%) 
Intracranial haematoma † 1     
# participants affected / at risk   1/335 (0.30%)   0/341 (0.00%) 
Psychiatric disorders     
Anxiety disorder due to a general medical condition † 1     
# participants affected / at risk   0/335 (0.00%)   1/341 (0.29%) 
Delusion † 1     
# participants affected / at risk   0/335 (0.00%)   1/341 (0.29%) 
Renal and urinary disorders     
Renal failure † 1     
# participants affected / at risk   0/335 (0.00%)   1/341 (0.29%) 
Urinary retention † 1     
# participants affected / at risk   1/335 (0.30%)   0/341 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Pneumonia aspiration † 1     
# participants affected / at risk   1/335 (0.30%)   1/341 (0.29%) 
Respiratory arrest † 1     
# participants affected / at risk   1/335 (0.30%)   0/341 (0.00%) 
Skin and subcutaneous tissue disorders     
Excessive skin † 1     
# participants affected / at risk   0/335 (0.00%)   1/341 (0.29%) 
Surgical and medical procedures     
Proctocolectomy † 1     
# participants affected / at risk   0/335 (0.00%)   1/341 (0.29%) 
Vascular disorders     
Deep vein thrombosis † 1     
# participants affected / at risk   0/335 (0.00%)   1/341 (0.29%) 
Hypotension † 1     
# participants affected / at risk   1/335 (0.30%)   1/341 (0.29%) 
Events were collected by systematic assessment
1 Term from vocabulary, MedDRA 10.1




  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information