Valproate in Dementia (VALID)
This study has been completed.
Sponsor:
Alzheimer's Disease Cooperative Study (ADCS)
Collaborator:
Information provided by (Responsible Party):
Alzheimer's Disease Cooperative Study (ADCS)
ClinicalTrials.gov Identifier:
NCT00071721
First received: October 29, 2003
Last updated: January 10, 2013
Last verified: January 2013
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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
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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| No text entered. |
Pre-Assignment Details
| Significant events and approaches for the overall study following participant enrollment, but prior to group assignment |
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| No text entered. |
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
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 |
| Total | Total of all reporting groups |
Baseline Measures
| Valproate | Placebo | Total | |
|---|---|---|---|
|
Number of Participants
[units: participants] |
153 | 160 | 313 |
|
Age
[units: years] Mean ± Standard Deviation |
74.9 ± 8.2 | 76.6 ± 7.4 | 75.7 ± 7.8 |
|
Gender
[units: participants] |
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| Female | 83 | 101 | 184 |
| Male | 70 | 59 | 129 |
|
Region of Enrollment
[units: participants] |
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| United States | 153 | 160 | 313 |
|
ADAScog
[1] [units: Units on a scale] Mean ± Standard Deviation |
29.4 ± 8.9 | 30.1 ± 9.8 | 29.8 ± 9.4 |
|
ADCS-ADL
[2] [units: Units on a scale] Mean ± Standard Deviation |
56.9 ± 11.8 | 54.9 ± 13 | 55.9 ± 12.4 |
|
CDR-SOB
[3] [units: Units on a scale] Mean ± Standard Deviation |
7.1 ± 2.7 | 7.5 ± 3.1 | 7.3 ± 2.9 |
|
CMAI
[4] [units: Units on a scale] Mean ± Standard Deviation |
10.9 ± 8.9 | 11.9 ± 10.4 | 11.4 ± 9.7 |
|
NPI
[5] [units: Units on a scale] Mean ± Standard Deviation |
2.6 ± 2.6 | 3.1 ± 2.6 | 2.9 ± 2.6 |
| [1] | 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. |
|---|---|
| [2] | 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. |
| [3] | 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. |
| [4] | 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. |
| [5] | 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. |
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 ] |
Hide Outcome Measure 2| Measure Type | Secondary |
|---|---|
| Measure Title | Cognitive Performance Assessed by the Alzheimer's Disease Assessment Scale-cognitive Subtest (ADAS-cog) |
| 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. |
| Time Frame | 24 months |
| Safety Issue | No |
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. |
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| No text entered. |
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 |
Measured Values
| Valproate | Placebo | |
|---|---|---|
|
Number of Participants Analyzed
[units: participants] |
153 | 160 |
|
Cognitive Performance Assessed by the Alzheimer's Disease Assessment Scale-cognitive Subtest (ADAS-cog)
[units: Units on a scale] Mean ± Standard Deviation |
42.3 ± 14.3 | 41.9 ± 14.4 |
No statistical analysis provided for Cognitive Performance Assessed by the Alzheimer's Disease Assessment Scale-cognitive Subtest (ADAS-cog)
| 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 ] |