NCT01302340 is a Phase 2 clinical trial of Delta-THC in Dementia, sponsored by Radboud University Medical Center.

Who is sponsoring NCT01302340?

NCT01302340 is sponsored by Radboud University Medical Center.

What drugs are being tested in NCT01302340?

Interventions in NCT01302340: Delta-THC, placebo, Delta-THC.

Is NCT01302340 still recruiting?

NCT01302340 is currently completed. Last updated 21 January 2014.

Last reviewed 2014-01-21 · How we verify

NCT01302340

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Two Phase, Repeated Crossover Study With Dose Escalation on Delta(9)-Tetrahydrocannabinol (Delta-THC) in Behavioral Disturbances in Dementia

Completed Phase 2 Last updated 21 January 2014

What this trial tests

Phase 2 trial testing Delta-THC in Dementia in 22 participants. Completed in 1 December 2013.

Timeline

1 September 2011

Primary endpoint
1 December 2013

1 December 2013

Quick facts

Lead sponsor	Radboud University Medical Center
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	quadruple
Primary purpose	treatment
Enrollment	22
Start date	1 September 2011
Primary completion	1 December 2013
Estimated completion	1 December 2013
Sites	2 locations across Netherlands

Drugs / interventions tested

Delta-THC — full drug profile →
placebo
Delta-THC — full drug profile →

Conditions studied

Dementia — all drugs for Dementia →

Sponsor

Radboud University Medical Center

Who can join

18 and older, any sex, with Dementia. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Neuropsychiatric Inventory (NPI)
Time frame: At day 3 and 10 during treatment blocks and after 1 month, 3 months and 6 months in the open label extension phase
Improvement in behavior compared to placebo is measured with the NPI, which is the standard measure of Neuro Psychiatric Symptoms in most clinical trials.

Sponsor's own description

Dementia is a common chronic condition, with predicted increasing prevalence. Nearly all patients with dementia will experience neuropsychiatric symptoms (NPS). This causes significant burden for the individual patients and their caregivers. Current treatment has only modest efficacy and important side-effects. Formulations with Δ9-tetrahydrocannabinol (THC), the psycho-active compound of cannabis, are currently being registered for spasms in multiple sclerosis and other diseases, and may have beneficial effects on NPS.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

Safety, pharmacodynamics, and pharmacokinetics of multiple oral doses of delta-9-tetrahydrocannabinol in older persons with dementia.
Ahmed AI, van den Elsen GA, Colbers A, Kramers C, et al · · 2015 · cited 47× · PMID 25752889 · DOI 10.1007/s00213-015-3889-y
Repurposed agents in the Alzheimer's disease drug development pipeline.
Bauzon J, Lee G, Cummings J. · · 2020 · cited 46× · PMID 32807237 · DOI 10.1186/s13195-020-00662-x
Management of Dementia-Related Psychosis, Agitation and Aggression: A Review of the Pharmacology and Clinical Effects of Potential Drug Candidates.
Marcinkowska M, Śniecikowska J, Fajkis N, Paśko P, et al · · 2020 · cited 37× · PMID 32052375 · DOI 10.1007/s40263-020-00707-7
Cannabinoids for the treatment of dementia.
Bosnjak Kuharic D, Markovic D, Brkovic T, Jeric Kegalj M, et al · · 2021 · cited 28× · PMID 34532852 · DOI 10.1002/14651858.cd012820.pub2
A perspective on Alzheimer's disease: exploring the potential of terminal/paradoxical lucidity and psychedelics.
Lin C, Du X, Wang X, Wang X. · · 2024 · PMID 39396013 · DOI 10.1186/s13024-024-00761-5

Verify or expand the search:

Other recruiting trials for Dementia

Currently open trials in the same condition.

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NCT07290387 — Tele-Savvy for Latino Caregivers · NA · recruiting
NCT06088810 — The Impact of Music Intervention on Sleep · NA · recruiting
NCT07482800 — Dementia in Fiction and Clinical Narratives · recruiting
NCT07392944 — Multicomponent Exercise Program on Physical Function, Cognition and Falls Risk Among Older Adults Living in Nursing Home · NA · recruiting

Other Radboud University Medical Center trials

Trials by the same sponsor.

NCT07485569 — Drug Repurposing in Thyroid Carcinoma: a Feasibility Trial · Phase 1 · not yet recruiting
NCT07514325 — MR-guided Adaptive Stereotactic Radiotherapy for Endometrial Cancer · NA · not yet recruiting
NCT07530263 — Deposition of Inhaled Liposomal Amphotericin B in Chronic Pulmonary Aspergillosis (CPA) · Phase 1 · not yet recruiting
NCT07532577 — Intranasal Insulin to Prevent Intensive Care Unit Delirium · Phase 2, PHASE3 · not yet recruiting
NCT07504172 — Real-world Effectiveness and Dosing Patterns of Tirzepatide in People With Obesity · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01302340 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Radboud University Medical Center
Last refreshed: 21 January 2014

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01302340.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing