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Trial record 2 of 6 for:    valproic acid alzheimer's

Valproate in Dementia (VALID)

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.
ClinicalTrials.gov Identifier: NCT00071721
Recruitment Status : Completed
First Posted : October 31, 2003
Results First Posted : October 20, 2010
Last Update Posted : September 25, 2014
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Alzheimer's Disease Cooperative Study (ADCS)

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Alzheimer Disease
Interventions Drug: Valproate
Drug: Placebo
Enrollment 313
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Valproate Placebo
Hide Arm/Group Description 250mg tablets beginning with one daily for one week, then two daily for one week, then titrated according to body weight and tolerability to achieve 10-12 mg/kg daily for 2 years, followed by a 2-month washout Placebo tablets beginning with one daily and increasing according to weight and perceived tolerability concerns for two years, followed by a 2-month washout
Period Title: Overall Study
Started 153 160
Completed 81 69
Not Completed 72 91
Arm/Group Title Valproate Placebo Total
Hide Arm/Group Description 250mg tablets beginning with one daily for one week, then two daily for one week, then titrated according to body weight and tolerability to achieve 10-12 mg/kg daily for 2 years, followed by a 2-month washout Placebo tablets beginning with one daily and increasing according to weight and perceived tolerability concerns for two years, followed by a 2-month washout Total of all reporting groups
Overall Number of Baseline Participants 153 160 313
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 153 participants 160 participants 313 participants
74.9  (8.2) 76.6  (7.4) 75.7  (7.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 153 participants 160 participants 313 participants
Female
83
  54.2%
101
  63.1%
184
  58.8%
Male
70
  45.8%
59
  36.9%
129
  41.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 153 participants 160 participants 313 participants
153 160 313
ADAScog   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 153 participants 160 participants 313 participants
29.4  (8.9) 30.1  (9.8) 29.8  (9.4)
[1]
Measure Description: Alzheimer's Disease Assessment Scale, cognitive sub-scale in points per year (ADAS-cog) is a psychometric measure sensitive to change in mild to moderate AD. The range of this instrument is 0 to 70 with higher numbers indicating greater impairment.
ADCS-ADL   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 153 participants 160 participants 313 participants
56.9  (11.8) 54.9  (13) 55.9  (12.4)
[1]
Measure Description: Alzheimer's Disease Cooperative Study Activities of Daily Living Score (ADCS-ADL) is a structured questionnaire about activities of daily living, administered to the subject's caregiver/study partner. The range of this instrument is 0 to 78 with lower numbers indicating greater impairment.
CDR-SOB   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 153 participants 160 participants 313 participants
7.1  (2.7) 7.5  (3.1) 7.3  (2.9)
[1]
Measure Description: Clinical Dementia Rating, Sum of Boxes (CDR-SOB) is a global rating of dementia severity based on the clinician's interpretation of the history and examination. The range of this instrument is 0 to 18 with higher numbers indicating greater impairment.
CMAI   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 153 participants 160 participants 313 participants
10.9  (8.9) 11.9  (10.4) 11.4  (9.7)
[1]
Measure Description: The Cohen-Mansfield Agitation Inventory (CMAI) is a 29-item caregiver rating questionnaire for the assessment of agitation in older persons. It includes descriptions of 29 agitated behaviors, each rated on a 7-point scale of frequency. The range of this instrument is 29 to 203 with higher numbers indicating greater impairment.
NPI   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 153 participants 160 participants 313 participants
2.6  (2.6) 3.1  (2.6) 2.9  (2.6)
[1]
Measure Description: The Neuropsychiatric Inventory (NPI) quantifies behavioral changes in dementia, including depression, anxiety, psychosis, agitation, sleep change, appetite change, and others. This is a structured questionnaire administered to the subject's caregiver/study partner. The range of this instrument is 0 to 120 with higher numbers indicating greater impairment.
1.Primary Outcome
Title Presence of Agitation and/or Psychosis Measured by the Neuropsychiatric Inventory (NPI) Combined With an Assessment of the Clinical Significance of Behavioral Change Rated by the Study Clinician
Hide Description NPI quantifies behavioral changes in dementia, including depression, anxiety, psychosis, agitation, and others. This is a questionnaire administered to the subject's study partner. The range of this instrument is 0 to 120 with higher numbers indicating greater impairment. To determine whether or not psychosis or agitation is present, there is no cutoff score but is based on the clinician’s judgment. In the NPI, the subject responds to ‘Yes’ or ‘No’ questions. Then it is determined how often psychosis or agitation occurs and if it is mild, moderate or severe.
Time Frame 24 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Valproate Placebo
Hide Arm/Group Description:
250mg tablets beginning with one daily for one week, then two daily for one week, then titrated according to body weight and tolerability to achieve 10-12 mg/kg daily for 2 years, followed by a 2-month washout
Placebo tablets beginning with one daily and increasing according to weight and perceived tolerability concerns for two years, followed by a 2-month washout
Overall Number of Participants Analyzed 153 160
Measure Type: Number
Unit of Measure: Participants
25 29
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Valproate, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.88
Comments [Not Specified]
Method Cox Proportional Hazards
Comments [Not Specified]
Method of Estimation Estimation Parameter Cox Proportional Hazard
Estimated Value 0.958
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Cognitive Performance Assessed by the Alzheimer's Disease Assessment Scale-cognitive Subtest (ADAS-cog)
Hide Description Alzheimer's Disease Assessment Scale, cognitive sub-scale in points per year (ADAS-cog) is a psychometric measure sensitive to change in mild to moderate AD. The range of this instrument is 0 to 70 with higher numbers indicating greater impairment.
Time Frame 24 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Valproate Placebo
Hide Arm/Group Description:
250mg tablets beginning with one daily for one week, then two daily for one week, then titrated according to body weight and tolerability to achieve 10-12 mg/kg daily for 2 years, followed by a 2-month washout
Placebo tablets beginning with one daily and increasing according to weight and perceived tolerability concerns for two years, followed by a 2-month washout
Overall Number of Participants Analyzed 153 160
Mean (Standard Deviation)
Unit of Measure: Units on a scale
42.3  (14.3) 41.9  (14.4)
3.Secondary Outcome
Title Functional Performance Assessed by the Alzheimer’s Disease Cooperative Study Activities of Daily Living (ADCS-ADL) Inventory
Hide Description Alzheimer's Disease Cooperative Study Activities of Daily Living Score (ADCS-ADL) is a structured questionnaire about activities of daily living, administered to the subject's caregiver/study partner. The range of this instrument is 0 to 78 with lower numbers indicating greater impairment.
Time Frame 24 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Valproate Placebo
Hide Arm/Group Description:
250mg tablets beginning with one daily for one week, then two daily for one week, then titrated according to body weight and tolerability to achieve 10-12 mg/kg daily for 2 years, followed by a 2-month washout
Placebo tablets beginning with one daily and increasing according to weight and perceived tolerability concerns for two years, followed by a 2-month washout
Overall Number of Participants Analyzed 153 160
Mean (Standard Deviation)
Unit of Measure: Units on a scale
35.1  (20.3) 41.0  (14.81)
4.Secondary Outcome
Title Global Severity of Dementia Using the CDR Sum of Boxes
Hide Description Clinical Dementia Rating, Sum of Boxes (CDR-SOB) is a global rating of dementia severity based on the clinician's interpretation of the history and examination. The range of this instrument is 0 to 18 with higher numbers indicating greater impairment.
Time Frame 24 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Valproate Placebo
Hide Arm/Group Description:
250mg tablets beginning with one daily for one week, then two daily for one week, then titrated according to body weight and tolerability to achieve 10-12 mg/kg daily for 2 years, followed by a 2-month washout
Placebo tablets beginning with one daily and increasing according to weight and perceived tolerability concerns for two years, followed by a 2-month washout
Overall Number of Participants Analyzed 153 160
Mean (Standard Deviation)
Unit of Measure: Units on a scale
12.0  (4.1) 11.5  (3.7)
5.Secondary Outcome
Title Agitation Measured by the Cohen-Mansfield Agitation Inventory (CMAI), Community Version
Hide Description The Cohen-Mansfield Agitation Inventory (CMAI) is a 29-item caregiver rating questionnaire for the assessment of agitation in older persons. It includes descriptions of 29 agitated behaviors, each rated on a 7-point scale of frequency. The range of this instrument is 29 to 203 with higher numbers indicating greater impairment.
Time Frame 24 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Valproate Placebo
Hide Arm/Group Description:
250mg tablets beginning with one daily for one week, then two daily for one week, then titrated according to body weight and tolerability to achieve 10-12 mg/kg daily for 2 years, followed by a 2-month washout
Placebo tablets beginning with one daily and increasing according to weight and perceived tolerability concerns for two years, followed by a 2-month washout
Overall Number of Participants Analyzed 153 160
Mean (Standard Deviation)
Unit of Measure: Units on a scale
10.6  (11.6) 12.1  (10.9)
6.Secondary Outcome
Title Participant’s Clinical Condition or Endpoint Assessed With the ADCS-Clinical Global Impression of Change (ADCS-CGIC)
Hide Description ADCS-Clinical Global Impression of Change (ADCS-CGIC) provides a means to reliably assess global change from baseline. It provides a semi-structured format to allow clinicians to gather necessary clinical information from both the participant and informant, in order to make an overall impression of clinical change. The range of this instrument is 1 to 7 with lower numbers indicating improvement and higher numbers indicating a worsened state.
Time Frame 24 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Valproate Placebo
Hide Arm/Group Description:
250mg tablets beginning with one daily for one week, then two daily for one week, then titrated according to body weight and tolerability to achieve 10-12 mg/kg daily for 2 years, followed by a 2-month washout
Placebo tablets beginning with one daily and increasing according to weight and perceived tolerability concerns for two years, followed by a 2-month washout
Overall Number of Participants Analyzed 153 160
Mean (Standard Deviation)
Unit of Measure: Units on a scale
5.7  (0.9) 5.5  (1.1)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Valproate Placebo
Hide Arm/Group Description 250mg tablets beginning with one daily for one week, then two daily for one week, then titrated according to body weight and tolerability to achieve 10-12 mg/kg daily for 2 years, followed by a 2-month washout Placebo tablets beginning with one daily and increasing according to weight and perceived tolerability concerns for two years, followed by a 2-month washout
All-Cause Mortality
Valproate Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Valproate Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   51/153 (33.33%)      62/160 (38.75%)    
Blood and lymphatic system disorders     
Anaemia  1/153 (0.65%)  1 2/160 (1.25%)  2
Cardiac disorders     
Angina pectoris  0/153 (0.00%)  0 1/160 (0.63%)  1
Angina unstable  1/153 (0.65%)  1 0/160 (0.00%)  0
Atrial fibrillation  3/153 (1.96%)  4 1/160 (0.63%)  2
Bradycardia  0/153 (0.00%)  0 1/160 (0.63%)  1
Cardiac disorder  1/153 (0.65%)  1 0/160 (0.00%)  0
Cardiac failure  0/153 (0.00%)  0 1/160 (0.63%)  1
Cardiac failure congestive  0/153 (0.00%)  0 1/160 (0.63%)  2
Myocardial infarction  0/153 (0.00%)  0 1/160 (0.63%)  1
Sinus tachycardia  0/153 (0.00%)  0 1/160 (0.63%)  1
Endocrine disorders     
Hypothyroidism  0/153 (0.00%)  0 1/160 (0.63%)  1
Gastrointestinal disorders     
Abdominal distension  1/153 (0.65%)  1 0/160 (0.00%)  0
Abdominal pain  1/153 (0.65%)  1 0/160 (0.00%)  0
Dysphagia  1/153 (0.65%)  1 0/160 (0.00%)  0
Faecaloma  1/153 (0.65%)  1 0/160 (0.00%)  0
Femoral hernia  0/153 (0.00%)  0 1/160 (0.63%)  1
Gastric haemorrhage  1/153 (0.65%)  1 0/160 (0.00%)  0
Gastric ulcer haemorrhage  0/153 (0.00%)  0 1/160 (0.63%)  1
Gastrointestinal haemorrhage  0/153 (0.00%)  0 2/160 (1.25%)  2
Oesophageal obstruction  1/153 (0.65%)  1 0/160 (0.00%)  0
Rectal haemorrhage  0/153 (0.00%)  0 1/160 (0.63%)  1
General disorders     
Chest pain  3/153 (1.96%)  3 1/160 (0.63%)  1
Death  5/153 (3.27%)  5 7/160 (4.38%)  7
Pyrexia  1/153 (0.65%)  1 0/160 (0.00%)  0
Hepatobiliary disorders     
Cholecystitis  0/153 (0.00%)  0 1/160 (0.63%)  1
Hepatic mass  1/153 (0.65%)  1 0/160 (0.00%)  0
Infections and infestations     
Bronchitis  1/153 (0.65%)  1 0/160 (0.00%)  0
Cellulitis  0/153 (0.00%)  0 1/160 (0.63%)  1
Enterococcal bacteraemia  0/153 (0.00%)  0 1/160 (0.63%)  1
Infection  0/153 (0.00%)  0 2/160 (1.25%)  2
Influenza  1/153 (0.65%)  1 0/160 (0.00%)  0
Kidney infection  2/153 (1.31%)  2 0/160 (0.00%)  0
Listeriosis  1/153 (0.65%)  1 0/160 (0.00%)  0
Nasopharyngitis  0/153 (0.00%)  0 1/160 (0.63%)  1
Pneumonia  5/153 (3.27%)  5 6/160 (3.75%)  6
Pneumonia bacterial  0/153 (0.00%)  0 1/160 (0.63%)  1
Postoperative infection  0/153 (0.00%)  0 1/160 (0.63%)  1
Urinary tract infection  4/153 (2.61%)  5 3/160 (1.88%)  3
Injury, poisoning and procedural complications     
Accidental overdose  1/153 (0.65%)  1 0/160 (0.00%)  0
Drug toxicity  1/153 (0.65%)  1 0/160 (0.00%)  0
Fall  6/153 (3.92%)  6 9/160 (5.63%)  10
Fractured sacrum  0/153 (0.00%)  0 1/160 (0.63%)  1
Head injury  1/153 (0.65%)  1 0/160 (0.00%)  0
Hip fracture  0/153 (0.00%)  0 2/160 (1.25%)  2
Joint dislocation  0/153 (0.00%)  0 1/160 (0.63%)  1
Subdural haematoma  1/153 (0.65%)  2 0/160 (0.00%)  0
Upper limb fracture  0/153 (0.00%)  0 1/160 (0.63%)  1
Investigations     
Liver function test abnormal  1/153 (0.65%)  1 0/160 (0.00%)  0
Metabolism and nutrition disorders     
Decreased appetite  0/153 (0.00%)  0 1/160 (0.63%)  1
Dehydration  3/153 (1.96%)  3 0/160 (0.00%)  0
Hypoglycaemia  1/153 (0.65%)  1 0/160 (0.00%)  0
Hypokalaemia  1/153 (0.65%)  1 0/160 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Arthralgia  1/153 (0.65%)  1 0/160 (0.00%)  0
Arthritis  0/153 (0.00%)  0 1/160 (0.63%)  1
Chondropathy  1/153 (0.65%)  1 0/160 (0.00%)  0
Muscular weakness  1/153 (0.65%)  1 0/160 (0.00%)  0
Musculoskeletal chest pain  0/153 (0.00%)  0 1/160 (0.63%)  1
Spondylolisthesis  1/153 (0.65%)  1 0/160 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Breast cancer  0/153 (0.00%)  0 1/160 (0.63%)  1
Colon cancer  0/153 (0.00%)  0 1/160 (0.63%)  1
Mantle cell lymphoma  0/153 (0.00%)  0 1/160 (0.63%)  1
Metastatic neoplasm  0/153 (0.00%)  0 1/160 (0.63%)  1
Prostate cancer  1/153 (0.65%)  1 0/160 (0.00%)  0
Rectal cancer  0/153 (0.00%)  0 1/160 (0.63%)  1
Nervous system disorders     
Cerebral artery occlusion  1/153 (0.65%)  1 0/160 (0.00%)  0
Cerebral infarction  0/153 (0.00%)  0 1/160 (0.63%)  1
Cerebrovascular accident  0/153 (0.00%)  0 1/160 (0.63%)  1
Convulsion  0/153 (0.00%)  0 4/160 (2.50%)  4
Coordination abnormal  0/153 (0.00%)  0 1/160 (0.63%)  1
Depressed level of consciousness  1/153 (0.65%)  1 1/160 (0.63%)  1
Dizziness  2/153 (1.31%)  2 1/160 (0.63%)  1
Loss of consciousness  0/153 (0.00%)  0 1/160 (0.63%)  1
Lumbar radiculopathy  0/153 (0.00%)  0 1/160 (0.63%)  1
Subdural haematoma  1/153 (0.65%)  1 0/160 (0.00%)  0
Subdural haemorrhage  1/153 (0.65%)  1 0/160 (0.00%)  0
Syncope  4/153 (2.61%)  4 2/160 (1.25%)  2
Transient ischaemic attack  1/153 (0.65%)  1 0/160 (0.00%)  0
Psychiatric disorders     
Abnormal behaviour  1/153 (0.65%)  1 0/160 (0.00%)  0
Agitation  0/153 (0.00%)  0 2/160 (1.25%)  2
Confusional state  2/153 (1.31%)  2 0/160 (0.00%)  0
Delirium  0/153 (0.00%)  0 1/160 (0.63%)  1
Hallucination  1/153 (0.65%)  1 0/160 (0.00%)  0
Lethargy  0/153 (0.00%)  0 1/160 (0.63%)  1
Mental disorder  0/153 (0.00%)  0 1/160 (0.63%)  1
Renal and urinary disorders     
Haematuria  1/153 (0.65%)  1 0/160 (0.00%)  0
Urinary incontinence  1/153 (0.65%)  1 0/160 (0.00%)  0
Urinary retention  1/153 (0.65%)  1 1/160 (0.63%)  1
Reproductive system and breast disorders     
Breast swelling  1/153 (0.65%)  1 0/160 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Dyspnoea  1/153 (0.65%)  1 3/160 (1.88%)  3
Pneumonia aspiration  0/153 (0.00%)  0 1/160 (0.63%)  1
Pulmonary embolism  0/153 (0.00%)  0 1/160 (0.63%)  1
Respiratory distress  0/153 (0.00%)  0 1/160 (0.63%)  1
Skin and subcutaneous tissue disorders     
Hyperhidrosis  0/153 (0.00%)  0 1/160 (0.63%)  1
Skin ulcer  1/153 (0.65%)  1 0/160 (0.00%)  0
Surgical and medical procedures     
Bladder repair  0/153 (0.00%)  0 1/160 (0.63%)  1
Breast reconstruction  0/153 (0.00%)  0 1/160 (0.63%)  1
Cardiac pacemaker replacement  1/153 (0.65%)  1 0/160 (0.00%)  0
Cholecystectomy  1/153 (0.65%)  1 1/160 (0.63%)  1
Gallbladder operation  1/153 (0.65%)  1 0/160 (0.00%)  0
Hip arthroplasty  1/153 (0.65%)  1 0/160 (0.00%)  0
Hospitalisation  0/153 (0.00%)  0 1/160 (0.63%)  1
Joint arthroplasty  0/153 (0.00%)  0 1/160 (0.63%)  1
Knee operation  0/153 (0.00%)  0 1/160 (0.63%)  1
Leg amputation  0/153 (0.00%)  0 1/160 (0.63%)  1
Lesion excision  1/153 (0.65%)  1 0/160 (0.00%)  0
Surgery  1/153 (0.65%)  1 0/160 (0.00%)  0
Uterine prolapse repair  0/153 (0.00%)  0 1/160 (0.63%)  1
Ventriculo-peritoneal shunt  0/153 (0.00%)  0 1/160 (0.63%)  1
Whole blood transfusion  0/153 (0.00%)  0 1/160 (0.63%)  1
Vascular disorders     
Deep vein thrombosis  1/153 (0.65%)  2 0/160 (0.00%)  0
Hypertension  1/153 (0.65%)  1 1/160 (0.63%)  1
Hypotension  0/153 (0.00%)  0 1/160 (0.63%)  1
Pulmonary embolism  0/153 (0.00%)  0 1/160 (0.63%)  1
Thrombosis  0/153 (0.00%)  0 1/160 (0.63%)  1
1
Term from vocabulary, MedDRA (8.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Valproate Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   145/153 (94.77%)      151/160 (94.38%)    
Eye disorders     
Vision blurred  10/153 (6.54%)  11 8/160 (5.00%)  8
Gastrointestinal disorders     
Abdominal discomfort  16/153 (10.46%)  19 13/160 (8.13%)  13
Constipation  26/153 (16.99%)  28 13/160 (8.13%)  16
Diarrhoea  38/153 (24.84%)  45 19/160 (11.88%)  24
Dry mouth  16/153 (10.46%)  16 15/160 (9.38%)  15
Faecal incontinence  8/153 (5.23%)  8 5/160 (3.13%)  5
Nausea  14/153 (9.15%)  16 10/160 (6.25%)  11
Vomiting  9/153 (5.88%)  10 7/160 (4.38%)  7
General disorders     
Asthenia  48/153 (31.37%)  52 35/160 (21.88%)  37
Chest pain  7/153 (4.58%)  9 8/160 (5.00%)  8
Oedema peripheral  10/153 (6.54%)  12 7/160 (4.38%)  7
Infections and infestations     
Bronchitis  7/153 (4.58%)  8 5/160 (3.13%)  6
Nasopharyngitis  11/153 (7.19%)  12 9/160 (5.63%)  13
Urinary tract infection  15/153 (9.80%)  19 17/160 (10.63%)  28
Injury, poisoning and procedural complications     
Fall  54/153 (35.29%)  85 42/160 (26.25%)  86
Investigations     
Weight decreased  11/153 (7.19%)  12 11/160 (6.88%)  11
Metabolism and nutrition disorders     
Decreased appetite  8/153 (5.23%)  9 7/160 (4.38%)  8
Musculoskeletal and connective tissue disorders     
Arthralgia  20/153 (13.07%)  21 12/160 (7.50%)  14
Back pain  21/153 (13.73%)  21 20/160 (12.50%)  20
Joint swelling  14/153 (9.15%)  15 10/160 (6.25%)  12
Muscular weakness  28/153 (18.30%)  32 14/160 (8.75%)  14
Myalgia  11/153 (7.19%)  12 11/160 (6.88%)  12
Nervous system disorders     
Disturbance in attention  40/153 (26.14%)  40 39/160 (24.38%)  39
Dizziness  23/153 (15.03%)  25 30/160 (18.75%)  36
Gait disturbance  51/153 (33.33%)  64 30/160 (18.75%)  35
Headache  16/153 (10.46%)  19 13/160 (8.13%)  16
Tremor  44/153 (28.76%)  51 22/160 (13.75%)  23
Psychiatric disorders     
Agitation  43/153 (28.10%)  50 54/160 (33.75%)  74
Anxiety  24/153 (15.69%)  29 38/160 (23.75%)  47
Apathy  9/153 (5.88%)  9 9/160 (5.63%)  9
Confusional state  76/153 (49.67%)  114 79/160 (49.38%)  111
Crying  23/153 (15.03%)  27 22/160 (13.75%)  24
Delusion  10/153 (6.54%)  11 14/160 (8.75%)  20
Depressed mood  35/153 (22.88%)  37 23/160 (14.37%)  26
Depression  18/153 (11.76%)  19 10/160 (6.25%)  11
Hallucination  9/153 (5.88%)  11 5/160 (3.13%)  5
Insomnia  20/153 (13.07%)  23 16/160 (10.00%)  18
Restlessness  28/153 (18.30%)  34 31/160 (19.38%)  39
Somnolence  66/153 (43.14%)  80 46/160 (28.75%)  51
Renal and urinary disorders     
Pollakiuria  23/153 (15.03%)  25 17/160 (10.63%)  19
Urinary incontinence  15/153 (9.80%)  18 15/160 (9.38%)  16
Respiratory, thoracic and mediastinal disorders     
Cough  21/153 (13.73%)  24 18/160 (11.25%)  22
Dyspnoea  19/153 (12.42%)  20 9/160 (5.63%)  9
Skin and subcutaneous tissue disorders     
Hyperhidrosis  4/153 (2.61%)  4 9/160 (5.63%)  9
Rash  7/153 (4.58%)  7 15/160 (9.38%)  17
1
Term from vocabulary, MedDRA (8.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Paul Aisen
Organization: Alzheimer's Disease Cooperative Study
Phone: 858-622-2028
Responsible Party: Alzheimer's Disease Cooperative Study (ADCS)
ClinicalTrials.gov Identifier: NCT00071721     History of Changes
Other Study ID Numbers: IA0043
1RC2AG036535 ( U.S. NIH Grant/Contract )
IND 67,222
ADCS Protocol ADC-022-VN
First Submitted: October 29, 2003
First Posted: October 31, 2003
Results First Submitted: July 6, 2010
Results First Posted: October 20, 2010
Last Update Posted: September 25, 2014