An interventional study to arrest the progression of cognitive decline in diabetic patients at high risk of developing Alzheimer's disease by reducing hypoglycemic events (low blood glucose).

English A pilot interventional study to arrest the progression of cognitive decline in diabetic patients at high risk of developing Alzheimer's disease by reducing hypoglycemic events.

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-004454-42-ES

Enrollment

188

Registered

2018-01-25

Start date

2018-04-27

Completion date

Unknown

Last updated

2018-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cognitive decline in patients affected with mild cognitive impairment MedDRA version: 20.0 Level: HLT Classification code 10012602 Term: Diabetes mellitus (incl subtypes) System Organ Class: 100000004860 MedDRA version: 20.0 Level: PT Classification code 10012267 Term: Dementia System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1 Level: LLT Classification code 10021005 Term: Hypoglycemia System Organ Class: 100000004861

Interventions

Trade Name: Tresiba Pharmaceutical Form: Solution for injection in pre-filled pen INN or Proposed INN: INSULIN DEGLUDEC CAS Number: 844439-96-9 Current Sponsor code: Insulin Tresiba Concentration unit

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Type 2 diabetic patients under treatment with insulin (with or without metformin) at least 5 years prior randomization. • Mild cognitive impaired confirmed by the neurophsycological tests at screening. • Aged 60 to 75 years • Written informed consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 188 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 188

Exclusion criteria

Exclusion criteria: • Family history of AD. • Patients with any type of dementia. • History of neurological or psychiatric conditions likely to substantially affect cognition, sensory deficits or mobility limitations that would prevent or substantially restrict the delivery of the assessment or intervention, as well as other significant health problems (for example, recent cardiovascular event, renal failure, treatment for cancer).

Design outcomes

Primary

Measure	Time frame
Main Objective: To determine whether the reduction of hypoglycemic events and glycemic variability in the intervention arm of treatment results in the arrest of functional decline and/or the conversion rate from MCI to AD in T2D population.;Secondary Objective: - To determine whether the reduction of hypoglycemic events alone is able to arrest the functional decline and/or the conversion rate from MCI to AD in T2D population. - To assess whether the reduction in glycemic variability alone is able to arrest the functional decline and/or the conversion rate from MCI to AD in T2D population.;Primary end point(s): Alzheimer's disease diagnosis.;Timepoint(s) of evaluation of this end point: At 6, 12, 18 and 24 months from baseline.	—

Measure

Time frame

Main Objective: To determine whether the reduction of hypoglycemic events and glycemic variability in the intervention arm of treatment results in the arrest of functional decline and/or the conversion rate from MCI to AD in T2D population.;Secondary Objective: - To determine whether the reduction of hypoglycemic events alone is able to arrest the functional decline and/or the conversion rate from MCI to AD in T2D population. - To assess whether the reduction in glycemic variability alone is able to arrest the functional decline and/or the conversion rate from MCI to AD in T2D population.;Primary end point(s): Alzheimer's disease diagnosis.;Timepoint(s) of evaluation of this end point: At 6, 12, 18 and 24 months from baseline.

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Secondary

Measure	Time frame
Secondary end point(s): Rate of hypoglycemic events and measurements of glycemic variability, respectively, in relation with Alzheimer’s disease diagnosis.;Timepoint(s) of evaluation of this end point: At 6, 12, 18 and 24 months from baseline.	—

Countries

Spain

Contacts

Public ContactVHIR

Vall d'Hebron Research Institute

olga.simo@vhir.org34934894172

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026