Trial Outcomes & Findings for A Study of the Safety and Efficacy of Memantine in Moderate to Severe Alzheimer's Disease (NCT NCT00322153)
NCT ID: NCT00322153
Last Updated: 2010-09-16
Results Overview
The SIB was developed for the evaluation of cognitive function in patients with more advanced dementia, and evaluates the areas of memory, language, praxis, orientation, and attention. The SIB test items consist of simple, one-step commands presented with gestural cues that are repeated if necessary. The test contains 51 items, and the range of possible scores is 0 to 100 (with 0 being the worst result). The SIB has been shown to be a valid and reliable instrument sensitive to longitudinal change.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
677 participants
Primary outcome timeframe
Baseline to week 24
Results posted on
2010-09-16
Participant Flow
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)
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.
Participant milestones
| Measure |
Placebo
Matching placebo oral administration once daily for 24 weeks.
|
Memantine ER
28mg once daily oral administration for 24 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
335
|
342
|
|
Overall Study
SAFETY POPULATION
|
335
|
341
|
|
Overall Study
COMPLETED
|
272
|
273
|
|
Overall Study
NOT COMPLETED
|
63
|
69
|
Reasons for withdrawal
| Measure |
Placebo
Matching placebo oral administration once daily for 24 weeks.
|
Memantine ER
28mg once daily oral administration for 24 weeks.
|
|---|---|---|
|
Overall Study
Adverse Event
|
21
|
34
|
|
Overall Study
Protocol Violation
|
6
|
14
|
|
Overall Study
Withdrawal by Subject
|
18
|
10
|
|
Overall Study
Lack of Efficacy
|
8
|
3
|
|
Overall Study
Lost to Follow-up
|
5
|
4
|
|
Overall Study
Withdrawn for other reasons
|
5
|
4
|
Baseline Characteristics
A Study of the Safety and Efficacy of Memantine in Moderate to Severe Alzheimer's Disease
Baseline characteristics by cohort
| Measure |
Placebo
n=335 Participants
Matching placebo oral administration once daily for 24 weeks.
|
Memantine ER
n=341 Participants
28mg once daily oral administration for 24 weeks.
|
Total
n=676 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
<= 64 years
|
26 participants
n=5 Participants
|
34 participants
n=7 Participants
|
60 participants
n=5 Participants
|
|
Age, Customized
65-74 years
|
79 participants
n=5 Participants
|
85 participants
n=7 Participants
|
164 participants
n=5 Participants
|
|
Age, Customized
75-84 years
|
179 participants
n=5 Participants
|
176 participants
n=7 Participants
|
355 participants
n=5 Participants
|
|
Age, Customized
>= 85 years
|
51 participants
n=5 Participants
|
46 participants
n=7 Participants
|
97 participants
n=5 Participants
|
|
Age Continuous
|
76.8 years
STANDARD_DEVIATION 7.76 • n=5 Participants
|
76.2 years
STANDARD_DEVIATION 8.35 • n=7 Participants
|
76.5 years
STANDARD_DEVIATION 8.07 • n=5 Participants
|
|
Sex: Female, Male
Female
|
243 Participants
n=5 Participants
|
244 Participants
n=7 Participants
|
487 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
92 Participants
n=5 Participants
|
97 Participants
n=7 Participants
|
189 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
85 participants
n=5 Participants
|
93 participants
n=7 Participants
|
178 participants
n=5 Participants
|
|
Region of Enrollment
Argentina
|
158 participants
n=5 Participants
|
153 participants
n=7 Participants
|
311 participants
n=5 Participants
|
|
Region of Enrollment
Chile
|
44 participants
n=5 Participants
|
46 participants
n=7 Participants
|
90 participants
n=5 Participants
|
|
Region of Enrollment
Mexico
|
48 participants
n=5 Participants
|
49 participants
n=7 Participants
|
97 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to week 24Population: Primary efficacy analysis was based on the Intent-to-Treat (ITT) Population. The ITT Population was consisted of all patients in the Safety Population who completed at least one post-Baseline efficacy assessment in SIB or CIBIC-Plus. The last-observation-carried-forward approach was used to impute missing post-Baseline values.
The SIB was developed for the evaluation of cognitive function in patients with more advanced dementia, and evaluates the areas of memory, language, praxis, orientation, and attention. The SIB test items consist of simple, one-step commands presented with gestural cues that are repeated if necessary. The test contains 51 items, and the range of possible scores is 0 to 100 (with 0 being the worst result). The SIB has been shown to be a valid and reliable instrument sensitive to longitudinal change.
Outcome measures
| Measure |
Placebo
n=327 Participants
Matching placebo oral administration once daily for 24 weeks.
|
Memantine ER
n=332 Participants
28mg once daily oral administration for 24 weeks.
|
|---|---|---|
|
Change From Baseline in Severe Impairment Battery (SIB) at Week 24 (LOCF)
|
-0.4 Units on a scale
Standard Error 0.65
|
2.2 Units on a scale
Standard Error 0.65
|
PRIMARY outcome
Timeframe: Week 24Population: Primary efficacy analysis was based on the Intent-to-Treat (ITT) Population. The ITT Population was consisted of all patients in the Safety Population who completed at least one post-Baseline efficacy assessment in SIB or CIBIC-Plus. The last-observation-carried-forward approach was used to impute missing post-Baseline values.
The CIBIC-Plus is a measure of an overall clinical effect and is based on a comprehensive evaluation at Baseline and later visits of four domains: general (overall clinical status), functional (including activities of daily living), cognitive, and behavioral. A skilled clinician interviews the patient, and includes information supplied by a knowledgeable caregiver. The CIBIC-Plus is a rating of the patient's global status relative to Baseline, ranging from a score of 1, indicating "marked improvement" to a score of 4, indicating "no change" to a score of 7, indicating "marked worsening."
Outcome measures
| Measure |
Placebo
n=328 Participants
Matching placebo oral administration once daily for 24 weeks.
|
Memantine ER
n=333 Participants
28mg once daily oral administration for 24 weeks.
|
|---|---|---|
|
Clinician's Interview-Based Impression of Change With Caregiver Input (CIBIC-plus) at Week 24 (LOCF)
|
4.1 Units on a scale
Standard Error 0.07
|
3.8 Units on a scale
Standard Error 0.07
|
SECONDARY outcome
Timeframe: Baseline to week 24Population: The secondary efficacy analysis was based on the ITT Population. The last-observation-carried-forward approach was used to impute missing post-Baseline values.
The ADCS-ADL19 modified inventory consists of 19 items used to measure the functional capabilities of patients with moderate to severe dementia. Each activity-of-daily-living (ADL) item comprises a series of hierarchical subquestions ranging from the highest level of independent performance to complete loss of ability to perform the ADL Inventory. The inventory is performed by interviewing a person in close contact with the patient and covers the most usual and consistent performance of the patient over the preceding 4 weeks. Response range is 0 (total disability) to 54 (total independence).
Outcome measures
| Measure |
Placebo
n=328 Participants
Matching placebo oral administration once daily for 24 weeks.
|
Memantine ER
n=331 Participants
28mg once daily oral administration for 24 weeks.
|
|---|---|---|
|
Change From Baseline in the 19-Item Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL19) Scale at Week 24 (LOCF)
|
-1.7 Units on a scale
Standard Error 0.44
|
-1.0 Units on a scale
Standard Error 0.44
|
Adverse Events
Placebo
Serious events: 21 serious events
Other events: 70 other events
Deaths: 0 deaths
Memantine ER
Serious events: 28 serious events
Other events: 67 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=335 participants at risk
Matching placebo oral administration once daily for 24 weeks.
|
Memantine ER
n=341 participants at risk
28mg once daily oral administration for 24 weeks.
|
|---|---|---|
|
Cardiac disorders
Atrioventricular block complete
|
0.00%
0/335 • 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.
|
0.29%
1/341 • 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.
|
|
Cardiac disorders
Bradycardia
|
0.30%
1/335 • 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.
|
0.29%
1/341 • 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.
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/335 • 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.
|
0.29%
1/341 • 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.
|
|
Cardiac disorders
Cardiac Arrest
|
0.30%
1/335 • 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.
|
0.00%
0/341 • 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.
|
|
Cardiac disorders
Cardiac Failure Congestive
|
0.90%
3/335 • 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.
|
0.00%
0/341 • 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.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.60%
2/335 • 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.
|
0.00%
0/341 • 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.
|
|
Cardiac disorders
Myocardial infarction
|
0.30%
1/335 • 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.
|
0.00%
0/341 • 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.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/335 • 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.
|
0.29%
1/341 • 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.
|
|
Gastrointestinal disorders
Rectal Prolapse
|
0.00%
0/335 • 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.
|
0.29%
1/341 • 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.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/335 • 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.
|
0.29%
1/341 • 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.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/335 • 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.
|
0.29%
1/341 • 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.
|
|
General disorders
Chest Pain
|
0.00%
0/335 • 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.
|
0.29%
1/341 • 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.
|
|
General disorders
General physical health deterioration
|
0.00%
0/335 • 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.
|
0.29%
1/341 • 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.
|
|
General disorders
Drowning
|
0.30%
1/335 • 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.
|
0.00%
0/341 • 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.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/335 • 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.
|
0.59%
2/341 • 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.
|
|
Infections and infestations
Urinary tract infection
|
0.90%
3/335 • 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.
|
0.59%
2/341 • 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.
|
|
Infections and infestations
Lobar Pneumonia
|
0.00%
0/335 • 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.
|
0.29%
1/341 • 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.
|
|
Infections and infestations
Meningitis bacterial
|
0.00%
0/335 • 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.
|
0.29%
1/341 • 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.
|
|
Infections and infestations
Bacteraemia
|
0.30%
1/335 • 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.
|
0.00%
0/341 • 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.
|
|
Infections and infestations
Herpes zoster
|
0.30%
1/335 • 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.
|
0.00%
0/341 • 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.
|
|
Injury, poisoning and procedural complications
Fall
|
1.5%
5/335 • 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.
|
0.59%
2/341 • 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.
|
|
Injury, poisoning and procedural complications
Pneumothorax traumatic
|
0.00%
0/335 • 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.
|
0.29%
1/341 • 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.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/335 • 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.
|
0.29%
1/341 • 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.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/335 • 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.
|
0.29%
1/341 • 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.
|
|
Injury, poisoning and procedural complications
Head Injury
|
0.30%
1/335 • 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.
|
0.00%
0/341 • 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.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.90%
3/335 • 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.
|
0.00%
0/341 • 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.
|
|
Injury, poisoning and procedural complications
Traumatic brain injury
|
0.30%
1/335 • 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.
|
0.00%
0/341 • 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.
|
|
Investigations
Anticoagulation drug level above therapeutic
|
0.00%
0/335 • 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.
|
0.29%
1/341 • 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.
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/335 • 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.
|
0.29%
1/341 • 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.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.30%
1/335 • 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.
|
0.00%
0/341 • 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.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.30%
1/335 • 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.
|
0.00%
0/341 • 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.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/335 • 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.
|
0.29%
1/341 • 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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cholesteatoma
|
0.00%
0/335 • 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.
|
0.29%
1/341 • 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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic carcinoma of the bladder
|
0.00%
0/335 • 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.
|
0.29%
1/341 • 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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal neoplasm
|
0.00%
0/335 • 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.
|
0.29%
1/341 • 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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.30%
1/335 • 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.
|
0.00%
0/341 • 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.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/335 • 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.
|
0.59%
2/341 • 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.
|
|
Nervous system disorders
Syncope
|
0.00%
0/335 • 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.
|
0.59%
2/341 • 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.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.30%
1/335 • 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.
|
0.29%
1/341 • 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.
|
|
Nervous system disorders
Dementia Alzheimer's type
|
0.00%
0/335 • 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.
|
0.29%
1/341 • 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.
|
|
Nervous system disorders
Facial paresis
|
0.00%
0/335 • 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.
|
0.29%
1/341 • 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.
|
|
Nervous system disorders
Ischaemic stroke
|
0.30%
1/335 • 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.
|
0.29%
1/341 • 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.
|
|
Nervous system disorders
Myoclonus
|
0.00%
0/335 • 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.
|
0.29%
1/341 • 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.
|
|
Nervous system disorders
Syncope vasovagal
|
0.00%
0/335 • 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.
|
0.29%
1/341 • 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.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/335 • 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.
|
0.29%
1/341 • 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.
|
|
Nervous system disorders
Convulsion
|
0.30%
1/335 • 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.
|
0.00%
0/341 • 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.
|
|
Nervous system disorders
Intracranial haematoma
|
0.30%
1/335 • 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.
|
0.00%
0/341 • 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.
|
|
Psychiatric disorders
Anxiety disorder due to a general medical condition
|
0.00%
0/335 • 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.
|
0.29%
1/341 • 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.
|
|
Psychiatric disorders
Delusion
|
0.00%
0/335 • 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.
|
0.29%
1/341 • 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.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/335 • 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.
|
0.29%
1/341 • 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.
|
|
Renal and urinary disorders
Urinary retention
|
0.30%
1/335 • 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.
|
0.00%
0/341 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.30%
1/335 • 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.
|
0.29%
1/341 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory arrest
|
0.30%
1/335 • 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.
|
0.00%
0/341 • 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.
|
|
Skin and subcutaneous tissue disorders
Excessive skin
|
0.00%
0/335 • 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.
|
0.29%
1/341 • 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.
|
|
Surgical and medical procedures
Proctocolectomy
|
0.00%
0/335 • 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.
|
0.29%
1/341 • 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.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/335 • 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.
|
0.29%
1/341 • 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.
|
|
Vascular disorders
Hypotension
|
0.30%
1/335 • 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.
|
0.29%
1/341 • 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.
|
Other adverse events
| Measure |
Placebo
n=335 participants at risk
Matching placebo oral administration once daily for 24 weeks.
|
Memantine ER
n=341 participants at risk
28mg once daily oral administration for 24 weeks.
|
|---|---|---|
|
Injury, poisoning and procedural complications
Fall
|
7.8%
26/335 • 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.
|
5.6%
19/341 • 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.
|
|
Infections and infestations
Urinary tract infection
|
7.2%
24/335 • 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.
|
5.6%
19/341 • 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.
|
|
Nervous system disorders
Headache
|
5.1%
17/335 • 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.
|
5.6%
19/341 • 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.
|
|
Gastrointestinal disorders
Diarrhoea
|
3.9%
13/335 • 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.
|
5.0%
17/341 • 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 Information
Results disclosure agreements
- Principal investigator is a sponsor employee Sponsor can review results communications prior to public release \& can embargo communications re: results for 90 days from time submitted to sponsor for review. PI shall not disclose sponsor's confidential info. Upon sponsor's request, PI shall delete any proprietary info \& shall not include raw data in pub. On sponsor's request, PI shall delay submission for any pub while sponsor files patent apps. If trial is multi-center, PI agrees that first publication shall be a multi-center pub.
- Publication restrictions are in place
Restriction type: OTHER