Trial · NCT00071721

Valproate in Dementia (VALID)

NCT00071721, Phase 3, Completed, Alzheimer's Disease Cooperative Study (ADCS); results first posted 2010-10-20

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Valproate in Dementia (VALID). Trials, record NCT00071721. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00071721

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Valproate in Dementia (VALID)
NCT number: NCT00071721
Status: Completed
Phases: Phase 3
Enrollment: 313 participants, actual
Lead sponsor: Alzheimer's Disease Cooperative Study (ADCS)
Conditions: Alzheimer Disease
Interventions: Valproate, Placebo
First posted: 2003-10-31
Last updated: 2014-09-25
Results first posted: 2010-10-20

Source ClinicalTrials.gov

Registered outcomes6

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
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	24 months	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.
Secondary	Cognitive Performance Assessed by the Alzheimer's Disease Assessment Scale-cognitive Subtest (ADAS-cog)	24 months	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.
Secondary	Functional Performance Assessed by the Alzheimer's Disease Cooperative Study Activities of Daily Living (ADCS-ADL) Inventory	24 months	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.
Secondary	Global Severity of Dementia Using the CDR Sum of Boxes	24 months	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.
Secondary	Agitation Measured by the Cohen-Mansfield Agitation Inventory (CMAI), Community Version	24 months	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.
Secondary	Participant's Clinical Condition or Endpoint Assessed With the ADCS-Clinical Global Impression of Change (ADCS-CGIC)	24 months	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.

Source ClinicalTrials.gov

Outcomes6

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Units	Measured as
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	24 months	Participants	NUMBER
SECONDARY	Cognitive Performance Assessed by the Alzheimer's Disease Assessment Scale-cognitive Subtest (ADAS-cog)	24 months	Units on a scale	MEAN
SECONDARY	Functional Performance Assessed by the Alzheimer's Disease Cooperative Study Activities of Daily Living (ADCS-ADL) Inventory	24 months	Units on a scale	MEAN
SECONDARY	Global Severity of Dementia Using the CDR Sum of Boxes	24 months	Units on a scale	MEAN
SECONDARY	Agitation Measured by the Cohen-Mansfield Agitation Inventory (CMAI), Community Version	24 months	Units on a scale	MEAN
SECONDARY	Participant's Clinical Condition or Endpoint Assessed With the ADCS-Clinical Global Impression of Change (ADCS-CGIC)	24 months	Units on a scale	MEAN

Source ClinicalTrials.gov

Results by group12

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
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	Valproate	25		Participants
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	Placebo	29		Participants
Cognitive Performance Assessed by the Alzheimer's Disease Assessment Scale-cognitive Subtest (ADAS-cog)	Valproate	42.3	Standard Deviation 14.3	Units on a scale
Cognitive Performance Assessed by the Alzheimer's Disease Assessment Scale-cognitive Subtest (ADAS-cog)	Placebo	41.9	Standard Deviation 14.4	Units on a scale
Functional Performance Assessed by the Alzheimer's Disease Cooperative Study Activities of Daily Living (ADCS-ADL) Inventory	Valproate	35.1	Standard Deviation 20.3	Units on a scale
Functional Performance Assessed by the Alzheimer's Disease Cooperative Study Activities of Daily Living (ADCS-ADL) Inventory	Placebo	41.0	Standard Deviation 14.81	Units on a scale
Global Severity of Dementia Using the CDR Sum of Boxes	Valproate	12.0	Standard Deviation 4.1	Units on a scale
Global Severity of Dementia Using the CDR Sum of Boxes	Placebo	11.5	Standard Deviation 3.7	Units on a scale
Agitation Measured by the Cohen-Mansfield Agitation Inventory (CMAI), Community Version	Valproate	10.6	Standard Deviation 11.6	Units on a scale
Agitation Measured by the Cohen-Mansfield Agitation Inventory (CMAI), Community Version	Placebo	12.1	Standard Deviation 10.9	Units on a scale

1 to 10 of 12Source ClinicalTrials.gov

See all 12 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Valproate	153
Overall Study	STARTED	Placebo	160
Overall Study	COMPLETED	Valproate	81
Overall Study	COMPLETED	Placebo	69
Overall Study	NOT COMPLETED	Valproate	72
Overall Study	NOT COMPLETED	Placebo	91

Source ClinicalTrials.gov

Adverse events318

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Abdominal discomfort	Gastrointestinal disorders	Valproate	16	153	19
other	Abdominal discomfort	Gastrointestinal disorders	Placebo	13	160	13
other	Agitation	Psychiatric disorders	Valproate	43	153	50
other	Agitation	Psychiatric disorders	Placebo	54	160	74
other	Anxiety	Psychiatric disorders	Valproate	24	153	29
other	Anxiety	Psychiatric disorders	Placebo	38	160	47
other	Apathy	Psychiatric disorders	Valproate	9	153	9
other	Apathy	Psychiatric disorders	Placebo	9	160	9
other	Arthralgia	Musculoskeletal and connective tissue disorders	Valproate	20	153	21
other	Arthralgia	Musculoskeletal and connective tissue disorders	Placebo	12	160	14

1 to 10 of 318Source ClinicalTrials.gov

See all 318 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Valproate
Total, all-cause mortality	Placebo
Total, other adverse events	Valproate	145	153
Total, other adverse events	Placebo	151	160
Total, serious adverse events	Valproate	51	153
Total, serious adverse events	Placebo	62	160

Source ClinicalTrials.gov

Papers5

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
10037507	BACKGROUND	PubMed
11126389	BACKGROUND	PubMed
12453674	BACKGROUND	PubMed
21810649	DERIVED	PubMed
39800465	DERIVED	PubMed

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
RC2AG036535	Amyloid Imaging, VMCI, and Analysis for ADNI	WEINER, MICHAEL W	NORTHERN CALIFORNIA INSTITUTE/RES/EDU	NATIONAL INSTITUTE ON AGING	2009 to 2010

Source NIH RePORTER

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Valproate vs Placebo: 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	Trial comparisons
Valproate vs Placebo: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00071721

GET https://conductscience.org/api/trials/v1/NCT00071721/events?page=2

API reference For AI assistants