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Valproate in Dementia (VALID)

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Alzheimer's Disease Cooperative Study (ADCS)
ClinicalTrials.gov Identifier:
NCT00071721
First received: October 29, 2003
Last updated: September 15, 2014
Last verified: September 2014
Results First Received: July 6, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Alzheimer Disease
Interventions: Drug: Valproate
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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Valproate 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 Placebo tablets beginning with one daily and increasing according to weight and perceived tolerability concerns for two years, followed by a 2-month washout

Participant Flow:   Overall Study
    Valproate     Placebo  
STARTED     153     160  
COMPLETED     81     69  
NOT COMPLETED     72     91  



  Baseline Characteristics


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   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   [ Time Frame: 24 months ]

2.  Secondary:   Cognitive Performance Assessed by the Alzheimer's Disease Assessment Scale-cognitive Subtest (ADAS-cog)   [ Time Frame: 24 months ]

3.  Secondary:   Functional Performance Assessed by the Alzheimer’s Disease Cooperative Study Activities of Daily Living (ADCS-ADL) Inventory   [ Time Frame: 24 months ]

4.  Secondary:   Global Severity of Dementia Using the CDR Sum of Boxes   [ Time Frame: 24 months ]

5.  Secondary:   Agitation Measured by the Cohen-Mansfield Agitation Inventory (CMAI), Community Version   [ Time Frame: 24 months ]

6.  Secondary:   Participant’s Clinical Condition or Endpoint Assessed With the ADCS-Clinical Global Impression of Change (ADCS-CGIC)   [ Time Frame: 24 months ]


  Serious Adverse Events


  Other Adverse Events
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Time Frame No text entered.
Additional Description No text entered.

Frequency Threshold
Threshold above which other adverse events are reported   5%  

Reporting Groups
  Description
Valproate 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 Placebo tablets beginning with one daily and increasing according to weight and perceived tolerability concerns for two years, followed by a 2-month washout

Other Adverse Events
    Valproate     Placebo  
Total, other (not including serious) adverse events      
# participants affected / at risk     145/153     151/160  
Eye disorders      
Vision blurred 1    
# participants affected / at risk     10/153 (6.54%)     8/160 (5.00%)  
# events     11     8  
Gastrointestinal disorders      
Abdominal discomfort 1    
# participants affected / at risk     16/153 (10.46%)     13/160 (8.13%)  
# events     19     13  
Constipation 1    
# participants affected / at risk     26/153 (16.99%)     13/160 (8.13%)  
# events     28     16  
Diarrhoea 1    
# participants affected / at risk     38/153 (24.84%)     19/160 (11.88%)  
# events     45     24  
Dry mouth 1    
# participants affected / at risk     16/153 (10.46%)     15/160 (9.38%)  
# events     16     15  
Faecal incontinence 1    
# participants affected / at risk     8/153 (5.23%)     5/160 (3.13%)  
# events     8     5  
Nausea 1    
# participants affected / at risk     14/153 (9.15%)     10/160 (6.25%)  
# events     16     11  
Vomiting 1    
# participants affected / at risk     9/153 (5.88%)     7/160 (4.38%)  
# events     10     7  
General disorders      
Asthenia 1    
# participants affected / at risk     48/153 (31.37%)     35/160 (21.88%)  
# events     52     37  
Chest pain 1    
# participants affected / at risk     7/153 (4.58%)     8/160 (5.00%)  
# events     9     8  
Oedema peripheral 1    
# participants affected / at risk     10/153 (6.54%)     7/160 (4.38%)  
# events     12     7  
Infections and infestations      
Bronchitis 1    
# participants affected / at risk     7/153 (4.58%)     5/160 (3.13%)  
# events     8     6  
Nasopharyngitis 1    
# participants affected / at risk     11/153 (7.19%)     9/160 (5.63%)  
# events     12     13  
Urinary tract infection 1    
# participants affected / at risk     15/153 (9.80%)     17/160 (10.63%)  
# events     19     28  
Injury, poisoning and procedural complications      
Fall 1    
# participants affected / at risk     54/153 (35.29%)     42/160 (26.25%)  
# events     85     86  
Investigations      
Weight decreased 1    
# participants affected / at risk     11/153 (7.19%)     11/160 (6.88%)  
# events     12     11  
Metabolism and nutrition disorders      
Decreased appetite 1    
# participants affected / at risk     8/153 (5.23%)     7/160 (4.38%)  
# events     9     8  
Musculoskeletal and connective tissue disorders      
Arthralgia 1    
# participants affected / at risk     20/153 (13.07%)     12/160 (7.50%)  
# events     21     14  
Back pain 1    
# participants affected / at risk     21/153 (13.73%)     20/160 (12.50%)  
# events     21     20  
Joint swelling 1    
# participants affected / at risk     14/153 (9.15%)     10/160 (6.25%)  
# events     15     12  
Muscular weakness 1    
# participants affected / at risk     28/153 (18.30%)     14/160 (8.75%)  
# events     32     14  
Myalgia 1    
# participants affected / at risk     11/153 (7.19%)     11/160 (6.88%)  
# events     12     12  
Nervous system disorders      
Disturbance in attention 1    
# participants affected / at risk     40/153 (26.14%)     39/160 (24.38%)  
# events     40     39  
Dizziness 1    
# participants affected / at risk     23/153 (15.03%)     30/160 (18.75%)  
# events     25     36  
Gait disturbance 1    
# participants affected / at risk     51/153 (33.33%)     30/160 (18.75%)  
# events     64     35  
Headache 1    
# participants affected / at risk     16/153 (10.46%)     13/160 (8.13%)  
# events     19     16  
Tremor 1    
# participants affected / at risk     44/153 (28.76%)     22/160 (13.75%)  
# events     51     23  
Psychiatric disorders      
Agitation 1    
# participants affected / at risk     43/153 (28.10%)     54/160 (33.75%)  
# events     50     74  
Anxiety 1    
# participants affected / at risk     24/153 (15.69%)     38/160 (23.75%)  
# events     29     47  
Apathy 1    
# participants affected / at risk     9/153 (5.88%)     9/160 (5.63%)  
# events     9     9  
Confusional state 1    
# participants affected / at risk     76/153 (49.67%)     79/160 (49.38%)  
# events     114     111  
Crying 1    
# participants affected / at risk     23/153 (15.03%)     22/160 (13.75%)  
# events     27     24  
Delusion 1    
# participants affected / at risk     10/153 (6.54%)     14/160 (8.75%)  
# events     11     20  
Depressed mood 1    
# participants affected / at risk     35/153 (22.88%)     23/160 (14.38%)  
# events     37     26  
Depression 1    
# participants affected / at risk     18/153 (11.76%)     10/160 (6.25%)  
# events     19     11  
Hallucination 1    
# participants affected / at risk     9/153 (5.88%)     5/160 (3.13%)  
# events     11     5  
Insomnia 1    
# participants affected / at risk     20/153 (13.07%)     16/160 (10.00%)  
# events     23     18  
Restlessness 1    
# participants affected / at risk     28/153 (18.30%)     31/160 (19.38%)  
# events     34     39  
Somnolence 1    
# participants affected / at risk     66/153 (43.14%)     46/160 (28.75%)  
# events     80     51  
Renal and urinary disorders      
Pollakiuria 1    
# participants affected / at risk     23/153 (15.03%)     17/160 (10.63%)  
# events     25     19  
Urinary incontinence 1    
# participants affected / at risk     15/153 (9.80%)     15/160 (9.38%)  
# events     18     16  
Respiratory, thoracic and mediastinal disorders      
Cough 1    
# participants affected / at risk     21/153 (13.73%)     18/160 (11.25%)  
# events     24     22  
Dyspnoea 1    
# participants affected / at risk     19/153 (12.42%)     9/160 (5.63%)  
# events     20     9  
Skin and subcutaneous tissue disorders      
Hyperhidrosis 1    
# participants affected / at risk     4/153 (2.61%)     9/160 (5.63%)  
# events     4     9  
Rash 1    
# participants affected / at risk     7/153 (4.58%)     15/160 (9.38%)  
# events     7     17  
1 Term from vocabulary, MedDRA (8.0)



  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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