Trial · NCT01608217

Delta-THC in Dementia

NCT01608217, Phase 2, Completed, Radboud University Medical Center

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Delta-THC in Dementia. Trials, record NCT01608217. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01608217

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Trial

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

Title: Delta-THC in Dementia
NCT number: NCT01608217
Status: Completed
Phases: Phase 2
Enrollment: 50 participants, actual
Lead sponsor: Radboud University Medical Center
Conditions: Behavioural Disturbances, Pain, Dementia, Alzheimer's Dementia, Vascular Dementia
Interventions: delta-9-tetrahydrocannabinol (delta-THC), Placebo, Acetaminophen, Acetaminophen
First posted: 2012-05-31
Last updated: 2014-06-30
Other registries' IDs: eudract:2011-005289-39

Source ClinicalTrials.gov

Registered outcomes9

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

List	Outcome	Time frame	Description
Primary	Neuropsychiatric Inventory (NPI)	Screening, baseline, T= 2 weeks (by telephone interview) and T=3 weeks	The NPI has been accepted as the standard measure of NPS in most clinical trials, due to high validity, good inter-rater reliability, high internal consistency and its sensitivity to drug treatment effects. In clinical practice as well as clinical research the NPI is the most commonly used instrument to assess behavioral changes. The NPI evaluates 12 behavioral domains. The frequency and severity of these behaviors is scored by the informal caregiver.
Secondary	Pain Assessment Checklist for Seniors with Limited Ability to Communicate Dutch version (PACSLAC-D)	baseline (T = 0) and T= 3 weeks	The PACSLAC-D is a brief version of Pain Assessment Checklist for Seniors with Limited Ability to Communicate in Dutch to observe pain related behavior It consists of 24 items, separated in three subscales (facial and vocal expressions, resistance/defense, social-economical aspects/mood). This scale is one of the few instruments in which the items are specifically geared towards elderly with dementia.
Secondary	Caregiver Clinical Global Impression of Change (CCGIC)	baseline (T=0), T= 2 wks (by telephone interview) and T=3 wks	The CCGIC is a 7-point Likert scale that assesses global change from baseline. The scale ranges from 1 ('very much improved') to 7 ('very much worse'). It has been frequently used in several psychopharmacological trials and in early clinical trials for antidementia drugs. When the caregiver rates the subject as changed compared to baseline, this change is, by definition, clinically meaningful.
Secondary	Cohen-Mansfield Agitation Inventory (CMAI)	baseline (T=0) and T= 3 weeks	The CMAI is selected to assess agitation and aggression. It is an internationally validated instrument, specifically developed to measure behavioral disturbance in people with dementia
Secondary	Quality of Life-Alzheimer's Disease Scale (QoL-AD)	baseline (T=0) and T= 3 weeks	The QoL-AD is a 13 -item self-report scale, using four-point Likert-scales, but can also be completed in conjunction with the interviewer. It is developed for assessment of quality of life in subjects with mild to moderate severe dementia, but there is also evidence for reliability in severe dementia.
Secondary	Barthel Index	baseline (T=0) and T = 3 weeks	The Barthel Index was originally developed to assess disability in patients with neuromuscular and musculoskeletal conditions receiving rehabilitation, but is also recommended for functional assessment in elderly. Barthel Index is an easy to conduct, 10-item scale which scores several primary activities of daily living.
Secondary	Paired Associates Learning test Wechsler Memory Scale Revised(PAL WMS-R)	baseline (T = 0) and T = 3 weeks	The PAL is a WMS subtest for assessment of episodic memory function. The PAL is sensitive to midtemporal lobe dysfunction and therefore suitable for assessment of effects of THC on hippocampal functioning. This test entails the presentation of 10 pairs of common words that have to be remembered (6 semantically related and 4 unrelated pairs). After presentation of the word pairs, the researcher reads aloud the first word of each pair, which has to be completed by the subject, thereby assessing the capacity to recall.
Secondary	Safety assessments	screening, baseline (T=0), T= 3 weeks. AE and compliance during telephone calls at T= 1week, T= 2 weeks and T= 5 weeks (follow up phone call)	Safety will be assessed by physical examination, including vital signs and internal examination. On indication extended physical (internal and neurological) examination or diagnostic tests can be performed. An ECG will be performed in all subjects during every visit. The occurrence of (serious) adverse events will be monitored, from first administration of study medication onwards. Weekly telephone calls are scheduled using a THC-specific symptom checklist to assess possible adverse events
Secondary	Verbal Rating Scale (VRS)	screening, baseline, T= 3 weeks, follow up (T= 5 weeks) and daily in a medication diary	The VRS is an ordinal self-reporting scale for assessment of pain intensity. It is a 6-point scale consisting of a list of phrases that describe increasing levels of pain intensity. The subject selects that phrase best characterizing his/her pain intensity at that moment. In agreement with the Interdisciplinary Consensus Statement on Assessment of Pain in Older Persons the VRS is chosen as the self-reporting assessment method for pain intensity in this group with mild to moderate impaired cognitive function.

Source ClinicalTrials.gov

Outcomes0

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

None in this release.

Results by group0

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

None in this release.

Participant flow0

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

None in this release.

Adverse events0

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

None in this release.

Adverse event totals0

The totals the trial posted for each group.

None in this release.

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
34532852	DERIVED

Source PubMed

Grants0

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.

None in this release.

Trial comparisons0

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

None in this release.

Tests1

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

Test	Named as
Paired Associate Learning	Secondary outcome

Source ConductCognition

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.

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GET https://conductscience.org/api/trials/v1/NCT01608217/registered

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