NCT03456349

Brief Summary

Multi-centre study of HTL0018318 in patients with Alzheimer's disease as an add-on to standard-of-care

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Nov 2017

Shorter than P25 for phase_1

Geographic Reach
4 countries

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 10, 2017

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 22, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 7, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 16, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 16, 2018

Completed
Last Updated

July 20, 2018

Status Verified

July 1, 2018

Enrollment Period

8 months

First QC Date

February 22, 2018

Last Update Submit

July 19, 2018

Conditions

Alzheimer's Disease

Keywords

Alzheimer's disease

Outcome Measures

Primary Outcomes (1)

  • Treatment emergent adverse events (TEAEs), Safety and Tolerability

    Baseline to Day 28

Study Arms (4)

Low dose

EXPERIMENTAL

HTL0018318

Drug: HTL0018318

Medium dose

EXPERIMENTAL

HTL0018318

Drug: HTL0018318

High dose

EXPERIMENTAL

HTL0018318

Drug: HTL0018318

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

HTL0018318DRUG

HTL0018318

High doseLow doseMedium dose
PlaceboDRUG

Placebo

Placebo

Eligibility Criteria

Age55 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnostic evidence of Alzheimer's disease according to the 2011 National Institutes of Aging-Alzheimer's Association (NIA-AA) criteria
  • Participants with Alzheimer's disease on stable standard of care

You may not qualify if:

  • Presence of illness apart from Alzheimer's disease that could contribute to cognitive dysfunction
  • A current or history of clinically significant suicidal ideation within the past 6 months
  • Subjects who have been on anti-cholinergic and/or anti muscarinic treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Syneos

Prague, Czechia

Location

Syneos

Warsaw, Poland

Location

Syneos

Bratislava, Slovakia

Location

Syneos

Barcelona, Spain

Location

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 22, 2018

First Posted

March 7, 2018

Study Start

November 10, 2017

Primary Completion

July 16, 2018

Study Completion

July 16, 2018

Last Updated

July 20, 2018

Record last verified: 2018-07

Locations

SL(1)PL(1)CZ(1)ES(1)